Table of Contents
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
10-Q
 
QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended June 30, December 31,
2021
OR
 
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
              
to
              
Commission file number    0-14902
 

MERIDIAN BIOSCIENCE, INC.
Incorporated under the laws of Ohio
31-0888197
(I.R.S. Employer Identification No.)
3471 River Hills Drive
Cincinnati, Ohio 45244
(513)
271-3700
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
  
Trading
Symbol(s)
  
Name of each exchange
on which registered
Common Stock, no par value
  
VIVO
  
NASDAQ Global Select Market
Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past
90 days.    
Yes
  ☒    No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files).    
Yes
  ☒    No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule
12b-2
of the Exchange Act.
 
Large accelerated filer   Accelerated filer 
    
Non-accelerated
filer
   Smaller reporting company 
    
Emerging growth company      
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2
of the Exchange Act).     Yes  ☐    No  
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
 
Class
 
Outstanding JulyJanuary 31, 20212022
Common Stock, no par value 
43,353,741
43,541,412

Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM
10-Q
 
      
Page(s)
 
PART I.
    
Item 1.
    
 
   1 
 
   2 
 
   3 
     
4-5
 
     6 
 
   7-20
7-16
 
Item 2.
     21-29
16-23
 
Item 3.
  23
Item 4.
   3023 
Item 4.
  30
PART II.
    
Item 1.
  24
Item 1A.
24
Item 6.
24
   30
Item 1A.
 30
Item 6.
31
3125 
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
10-Q
contains forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues”, “estimates”, “anticipates”, “projects”, “plans”, “seeks”, “may”, “will”, “expects”, “intends”, “believes”, “signals”, “should”, “can” and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian Bioscience, Inc. (“Meridian” or “the Company”) expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted net earnings, sales, product demand, net revenues, operating margin, other guidance and the impact of
COVID-19
on its business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian’s forward-looking statements are, and will be, based on management’s then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:

Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which the Company’s customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products, as can the uncertainty of regulatory approvals and the regulatory process (including the currently ongoing study and other FDA actions regarding the Company’s LeadCare products). The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and that the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention, and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. Meridian cannot predict the outcome of future goodwill impairment testing and the impact of possible goodwill impairments on Meridian’s earnings and financial results. Meridian cannot predict the possible impact of U.S. health care legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act – and any modification or repeal of any of the provisions thereofof current U.S. health care legislation that might be initiated by Congress or the presidential administration, and any similar initiatives in other countries on its results of operations. Efforts to reduce the U.S. federal deficit, breaches of Meridian’s information technology systems, trade wars, increased tariffs, and natural disasters and other events could have a materially adverse effect on Meridian’s results of operations and net revenues. The Company can make no assurances that a material weakness in its internal control over financial reporting will not be identified in the future, which if identified and not properly corrected, could materially adversely affect its operations and result in material misstatements in its consolidated financial statements. Meridian also is subject to risks and uncertainties related to disruptions to or reductions in business operations or prospects due to pandemics, epidemics, widespread health emergencies, or outbreaks of infectious diseases such as
COVID-19.
In addition to the factors described in this paragraph, as well as those factors identified from time to time in the Company’s filings with the Securities and Exchange Commission, Part I, Item 1A Risk Factors of the Company’s most recent Annual Report on Form
10-K
contains a list and description of uncertainties, risks and other matters that may affect the Company. Readers should carefully review these forward-looking statements and risk factors, and not place undue reliance on the Company’s forward-looking statements.

Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (Unaudited)
(dollar and share amounts in thousands, except per share data)
 
        
  
Three Months Ended
 
Nine Months Ended
 
  
June 30,
 
June 30,
   
Three Months
Ended
December 31,
 
  
2021
 
2020
 
2021
 
2020
   
2021
 
2020
 
NET REVENUES
  $63,511  $84,797  $241,692  $189,514   $88,341  $92,917 
COST OF SALES
   26,400   28,814   85,261   71,334    39,182   31,369 
  
 
  
 
  
 
  
 
   
 
  
 
 
GROSS PROFIT
   37,111   55,983   156,431   118,180    49,159   61,548 
  
 
  
 
  
 
  
 
   
 
  
 
 
OPERATING EXPENSES
              
Research and development
   6,083   6,668   17,799   16,746    6,194   5,651 
Selling and marketing
   6,209   6,282   19,770   19,539    7,741   7,021 
General and administrative
   11,964   12,624   36,827   32,236    14,660   11,938 
Acquisition-related costs
   300   1,641   300   3,428 
Selected legal costs
   281   1,227 
Change in fair value of acquisition consideration
   (3,563  (6,124  (5,505  (7,428   0     1,047 
Restructuring costs
   0     93   0     620 
Selected legal costs
   438   134   2,695   1,189 
  
 
  
 
  
 
  
 
   
 
  
 
 
Total operating expenses
   21,431   21,318   71,886   66,330    28,876   26,884 
  
 
  
 
  
 
  
 
   
 
  
 
 
OPERATING INCOME
   15,680   34,665   84,545   51,850    20,283   34,664 
  
OTHER INCOME (EXPENSE)
              
Interest income
   0     3   15   137    1   9 
Interest expense
   (444  (703  (1,450  (2,002   (372  (534
RADx grant income
   0     0     1,000   0      0     800 
Other, net
   59   908   (1,515  1,561    (161  (691
  
 
  
 
  
 
  
 
   
 
  
 
 
Total other income (expense)
   (385  208   (1,950  (304
Total other expense, net
   (532  (416
  
 
  
 
  
 
  
 
   
 
  
 
 
EARNINGS BEFORE INCOME TAXES
   15,295   34,873   82,595   51,546    19,751   34,248 
  
INCOME TAX PROVISION
   3,626   7,366   17,845   11,853    4,411   7,469 
  
 
  
 
  
 
  
 
   
 
  
 
 
NET EARNINGS
  $11,669  $27,507  $64,750  $39,693   $15,340  $26,779 
  
 
  
 
  
 
  
 
   
 
  
 
 
BASIC EARNINGS PER COMMON SHARE
  $0.27  $0.64  $1.50  $0.93   $0.35  $0.62 
DILUTED EARNINGS PER COMMON SHARE
  $0.26  $0.64  $1.47  $0.92   $0.35  $0.61 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC
   43,334   42,837   43,226   42,819    43,439   43,098 
EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARE UNITS
   763   436   780   219    589   681 
  
 
  
 
  
 
  
 
   
 
  
 
 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED
   44,097   43,273   44,006   43,038    44,028   43,779 
  
 
  
 
  
 
  
 
   
 
  
 
 
ANTI-DILUTIVE SECURITIES:
              
Common share options and restricted share units
   190   854   180   1,298    425   258 
  
 
  
 
  
 
  
 
   
 
  
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Income (Unaudited)
(dollar amounts in thousands)
 
        
  
Three Months Ended
June 30,
 
Nine Months Ended
June 30,
   
Three Months Ended
December 31,
 
  
2021
 
2020
 
2021
 
2020
   
2021
 
2020
 
NET EARNINGS
  $11,669  $27,507  $64,750  $39,693   $15,340  $26,779 
Other comprehensive income (loss):
         
Other comprehensive
(loss) income:
     
Foreign currency translation adjustment
   41  597  3,421  579    (58 3,301 
Unrealized gain (loss) on cash flow hedge
   9  (390 469  (703
Unrealized gain on cash flow hedge
   550  21 
Reclassification of amortization of gain on cash flow hedge
   0    (77 (154 (231   0    (77
Income taxes related to items of other comprehensive income (loss)
   (2 115  (68 230 
Income taxes related to items of other
comprehensive (loss) income
   (135 14 
  
 
  
 
  
 
  
 
   
 
  
 
 
Other comprehensive income (loss), net of tax
   48  245  3,668  (125
Other comprehensive income, net of tax
   357  3,259 
  
 
  
 
  
 
  
 
   
 
  
 
 
COMPREHENSIVE INCOME
  $11,717  $27,752  $68,418  $39,568   $15,697  $30,038 
  
 
  
 
  
 
  
 
   
 
  
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (Unaudited)
(dollar amounts in thousands)
 
         
Nine Months Ended June 30,
  
2021
  
2020
 
CASH FLOWS FROM OPERATING ACTIVITIES
         
Net earnings
  $64,750  $39,693 
Non-cash
items included in net earnings:
         
Depreciation of property, plant and equipment
   4,729   3,762 
Amortization of intangible assets
   6,453   5,604 
Stock compensation expense
   3,170   2,809 
Deferred income taxes
   (35  2,214 
Change in fair value of acquisition consideration
   (5,505  (7,428
Change in the following:
         
Accounts receivable
   (2,363  (6,352
Inventories
   (11,831  (17,828
Prepaid expenses and other current assets
   (1,965  68 
Accounts payable and accrued expenses
   (2,252  4,422 
Income taxes payable
   (2,317  3,401 
Other, net
   (448  1,315 
   
 
 
  
 
 
 
Net cash provided by operating activities
   52,386   31,680 
   
 
 
  
 
 
 
CASH FLOWS FROM INVESTING ACTIVITIES
         
Purchase of property, plant and equipment
   (16,407  (2,471
Payment of acquisition consideration holdback
   (5,000  —   
Acquisition of Exalenz, net of cash acquired
   —     (51,299
   
 
 
  
 
 
 
Net cash used in investing activities
   (21,407  (53,770
   
 
 
  
 
 
 
CASH FLOWS FROM FINANCING ACTIVITIES
         
Payment on revolving credit facility
   (18,824  (27,000
Proceeds from revolving credit facility
   —     50,000 
Payment of debt issuance costs
   —     (116
Proceeds from exercise of stock options
   2,939   —   
   
 
 
  
 
 
 
Net cash (used in) provided by financing activities
   (15,885  22,884 
   
 
 
  
 
 
 
Effect of Exchange Rate Changes on Cash and Cash Equivalents
   1,404   254 
   
 
 
  
 
 
 
Net Increase in Cash and Cash Equivalents
   16,498   1,048 
Cash and Cash Equivalents at Beginning of Period
   53,514   62,397 
   
 
 
  
 
 
 
Cash and Cash Equivalents at End of Period
  $70,012  $63,445 
   
 
 
  
 
 
 
   
Three Months Ended
December 31,
 
   
2021
  
2020
 
CASH FLOWS FROM OPERATING ACTIVITIES
   
Net earnings
  $ 15,340  $ 26,779 
Non-cash
items included in net earnings:
         
Depreciation of property, plant and equipment
   1,700   1,508 
Amortization of intangible assets
   2,483   2,221 
Stock-based compensation
   1,903   1,241 
Deferred income taxes
   927   (852
Change in fair value of acquisition consideration
   0     1,047 
Change in the following:
         
Accounts receivable
   9,424   (1,776
Inventories
   2,093   (5,941
Prepaid expenses and other current assets
   200   2,682 
Accounts payable and accrued expenses
   1,018   (5,826
Income taxes payable
   1,113   4,032 
Other, net
   (646  6 
   
 
 
  
 
 
 
Net cash provided by operating activities
   35,555   25,121 
   
 
 
  
 
 
 
CASH FLOWS FROM INVESTING ACTIVITIES
         
Purchase of property, plant and equipment
   (1,708  (2,086
Payment of acquisition consideration holdback
   0     (5,000
   
 
 
  
 
 
 
Net cash used
in
investing activities
   (1,708  (7,086
   
 
 
  
 
 
 
CASH FLOWS FROM FINANCING ACTIVITIES
         
Payment on revolving credit facility
   (10,000  (10,000
Payment of
deferred financing costs
   (404  0   
Proceeds from exercise of stock options
   80   

 
Employee taxes 
paid upon net share settlement of restricted share units
   (763  0   
   
 
 
  
 
 
 
Net cash used
in
financing activities
   (11,087  (10,000
   
 
 
  
 
 
 
Effect of Exchange Rate Changes on Cash and Cash Equivalents
   198   1,644 
   
 
 
  
 
 
 
Net Increase in Cash and Cash Equivalents
   22,958   9,679 
Cash and Cash Equivalents at Beginning of Period
   49,771   53,514 
   
 
 
  
 
 
 
Cash and Cash Equivalents at End of Period
  $72,729  $63,193 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
ASSETS
 
  
June 30,
2021

(Unaudited)
   
September 30,
2020
   
December 31,
2021

(Unaudited)
   
September 30,
2021
 
CURRENT ASSETS
            
Cash and cash equivalents
  $70,012   $53,514   $72,729   $49,771 
Accounts receivable, less allowances of $514 and $513, respectively
   42,258    38,512 
Accounts receivable, less allowances of $1,293 and $1,078,
respectively
   44,300    53,568 
Inventories, net
   71,813    61,264    74,198    76,842 
Prepaid expenses and other current assets
   10,896    8,900    12,426    12,626 
  
 
   
 
   
 
   
 
 
Total current assets
   194,979    162,190    203,653    192,807 
  
 
   
 
   
 
   
 
 
PROPERTY, PLANT AND EQUIPMENT, at Cost
            
Land
   993    991    987    989 
Buildings and improvements
   32,372    32,188    33,009    32,765 
Machinery, equipment and furniture
   77,429    69,854    79,438    78,410 
Construction in progress
   11,555    1,200    10,352    9,991 
  
 
   
 
   
 
   
 
 
Subtotal
   122,349    104,233    123,786    122,155 
Less: accumulated depreciation and amortization
   77,669    73,113    80,500    78,941 
  
 
   
 
   
 
   
 
 
Property, plant and equipment, net
   44,680    31,120    43,286    43,214 
  
 
   
 
   
 
   
 
 
OTHER ASSETS
            
Goodwill
   115,315    114,186    114,713    114,668 
Other intangible assets, net
   76,744    83,197    81,658    84,151 
Right-of-use
assets, net
   6,384    6,336    5,431    5,786 
Deferred income taxes
   8,073    7,647    8,813    8,731 
Other assets
   395    585    1,086    365 
  
 
   
 
   
 
   
 
 
Total other assets
   206,911    211,951    211,701    213,701 
  
 
   
 
   
 
   
 
 
TOTAL ASSETS
  $446,570   $405,261   $458,640   $449,722 
  
 
   
 
   
 
   
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(dollar amounts in thousands)
LIABILITIES AND SHAREHOLDERS’ EQUITY
 
  
June 30,
2021

(Unaudited)
   
September 30,
2020
   
December 31,
2021

(Unaudited)
   
September 30,
2021
 
CURRENT LIABILITIES
            
Accounts payable
  $13,103   $11,969   $16,293   $11,701 
Accrued employee compensation costs
   14,026    16,661    12,029    16,853 
Current portion of acquisition consideration
   0      12,619 
Accrued product recall costs
   4,269    5,100 
Acquisition consideration
   1,000    0   
Current operating lease obligations
   2,059    1,789    2,057    1,990 
Current government grant obligations
   735    600    765    638 
Other accrued expenses
   4,870    5,362    8,667    7,027 
Income taxes payable
   1,909    3,524    4,866    3,848 
  
 
   
 
   
 
   
 
 
Total current liabilities
   36,702    52,524    49,946    47,157 
  
 
   
 
   
 
   
 
 
NON-CURRENT
LIABILITIES
            
Acquisition consideration
   15,404    13,290    0      1,000 
Post-employment benefits
   2,314    2,493    2,169    2,253 
Fair value of interest rate swaps
   245    713 
Long-term operating lease obligations
   4,477    4,678    3,529    3,932 
Long-term debt
   50,000    68,824    50,000    60,000 
Government grant obligations
   10,512    10,524    5,068    5,176 
Long-term income taxes payable
   374    549    469    469 
Deferred income taxes
   4,195    3,804    2,067    1,055 
Other
non-current
liabilities
   191    233    173    378 
  
 
   
 
   
 
   
 
 
Total
non-current
liabilities
   87,712    105,108    63,475    74,263 
  
 
   
 
   
 
   
 
 
COMMITMENTS AND CONTINGENCIES
                
  
SHAREHOLDERS’ EQUITY
            
Preferred stock, 0 par value; 1,000,000 shares authorized; NaN issued
   0—      0—      0—      0—   
Common shares, 0 par value; 71,000,000 shares authorized, 43,352,998 and 43,068,842 shares issued, respectively
   0—      0—   
Common shares, 0 par value; 71,000,000 shares authorized, 43,514,258 and 43,361,898 shares
issued and outstanding, respectively
   0—      0—   
Additional
paid-in
capital
   146,304    140,195    148,623    147,403 
Retained earnings
   174,044    109,294    196,041    180,701 
Accumulated other comprehensive income (loss)
   1,808    (1,860
Accumulated other comprehensive income
   555    198 
  
 
   
 
   
 
   
 
 
Total shareholders’ equity
   322,156    247,629    345,219    328,302 
  
 
   
 
   
 
   
 
 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $446,570   $405,261   $458,640   $449,722 
  
 
   
 
   
 
   
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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Table of Contents
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited)
(dollar and share amounts in thousands)
 
          
  Common
Shares
Issued
   Additional
Paid-In

Capital
 Retained
Earnings
   Accumulated Other
Comprehensive
Income (Loss)
 Total
Shareholders’
Equity
   Common
Shares
   
Additional
Paid-In

Capital
 Retained
Earnings
   Accumulated Other
Comprehensive
Income (Loss)
 Total
Shareholders’
Equity
 
THREE MONTHS ENDED JUNE 30, 2021
             
Balance at March 31, 2021
   43,329   $145,338  $162,375   $1,760  $309,473 
Balance at September 30, 2021
   43,362   $147,403  $180,701   $198  $328,302 
Conversion of restricted share units and exercise of stock options
   24    87   —      —     87    152    (683  —      —     (683
Stock compensation expense
   —      879   —      —     879    —      1,903   —      —     1,903 
Net earnings
   —      —     11,669    —     11,669    —      —     15,340    —     15,340 
Foreign currency translation adjustment
   —      —     —      41   41    —      —     —      (58  (58
Hedging activity, net of tax
   —      —     —      7   7    —      —     —      415   415 
  
 
   
 
  
 
   
 
  
 
   
 
   
 
  
 
   
 
  
 
 
Balance at June 30, 2021
   43,353   $146,304  $174,044   $1,808  $322,156 
Balance at December 31, 2021
   43,514   $148,623  $196,041   $555  $345,219 
  
 
   
 
  
 
   
 
  
 
                
THREE MONTHS ENDED JUNE 30, 2020
             
Balance at March 31, 2020
   42,831   $134,584  $75,294   $(5,345 $204,533 
Conversion of restricted share units and exercise of stock options
   8    —     —      —     —   
Stock compensation expense
   —      1,050   —      —     1,050 
Net earnings
   —      —     27,507    —     27,507 
Foreign currency translation adjustment
   —      —     —      597   597 
Hedging activity, net of tax
   —      —     —      (352  (352
  
 
   
 
  
 
   
 
  
 
 
Balance at June 30, 2020
   42,839   $135,634  $102,801   $(5,100 $233,335 
  
 
   
 
  
 
   
 
  
 
 
 
  Common
Shares
Issued
   Additional
Paid-In

Capital
 Retained
Earnings
   Accumulated Other
Comprehensive
Income (Loss)
 Total
Shareholders’
Equity
 
NINE MONTHS ENDED JUNE 30, 2021
             
Balance at September 30, 2020
   43,069   $140,195  $109,294   $(1,860 $247,629    43,069   $140,195  $109,294   $(1,860 $247,629 
Conversion of restricted share units and exercise of stock options
   284    2,939   —      —     2,939    55    (41  —      —     (41
Stock compensation expense
   —      3,170   —      —     3,170    —      1,241   —      —     1,241 
Net earnings
   —      —     64,750    —     64,750    —      —     26,779    —     26,779 
Foreign currency translation adjustment
   —      —     —      3,421   3,421    —      —     —      3,301   3,301 
Hedging activity, net of tax
   —      —     —      247   247    —      —     —      (42  (42
  
 
   
 
  
 
   
 
  
 
   
 
   
 
  
 
   
 
  
 
 
Balance at June 30, 2021
   43,353   $146,304  $174,044   $1,808  $322,156 
Balance at December 31, 2020
   43,124   $141,395  $136,073   $1,399  $278,867 
  
 
   
 
  
 
   
 
  
 
   
 
   
 
  
 
   
 
  
 
 
NINE MONTHS ENDED JUNE 30, 2020
             
Balance at September 30, 2019
   42,712   $132,834  $63,108   $(4,975 $190,967 
Conversion of restricted share units and exercise of stock options
   127    (9  —      —     (9
Stock compensation expense
   —      2,809   —      —     2,809 
Net earnings
   —      —     39,693    —     39,693 
Foreign currency translation adjustment
   —      —     —      579   579 
Hedging activity, net of tax
   —      —     —      (704  (704
  
 
   
 
  
 
   
 
  
 
 
Balance at June 30, 2020
   42,839   $135,634  $102,801   $(5,100 $233,335 
  
 
   
 
  
 
   
 
  
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
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MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Dollars in Thousands, Except Per Share Amounts
(Unaudited)
 
1.
Nature of Business
Meridian Bioscience, Inc. (“Meridian” or “the Company”) was formed in 1976 and functions as a fully-integrated life science company with principal businesses in: (i) the development, manufacture, sale and distribution of diagnostic testing systems and kits, primarily for certain gastrointestinal and respiratory infectious diseases, and elevated blood lead levels; and (ii) the manufacture and distribution of bulk antigens, antibodies, immunoassay blocking reagents, various Polymerase Chain Reaction (“PCR”) master mixes, and bioresearch reagents used by other diagnostic manufacturers and researchers.
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of: (i) manufacturing operations for infectious disease products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; (ii) manufacturing operations for blood chemistry products in Billerica, Massachusetts (near Boston);Massachusetts; and (iii) the sale and distribution of diagnostics products domestically and abroad. This segment’s products are used by hospitals, reference labs and physician offices to detect infectious diseases and elevated lead levels in blood.
The Life Science segment consists of: (i) manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and Luckenwalde, Germany; and (ii) the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, in Beijing, China to pursue revenue opportunities in Asia. This segment’s products are used by manufacturers and researchers in a variety of applications (e.g.,
in-vitro
in vitro medical device manufacturing, microRNA detection, next-generation sequencing, plant genotyping, and mutation detection, among others).
 
2.
Basis of Presentation
The Condensed Consolidated Financial Statements are unaudited and are prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) for interim financial information, and the rules and regulations of the Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of Management, the Condensed Consolidated Financial Statements include all normal adjustments and disclosures necessary to present fairly the Company’s consolidated financial position as of June 30,December 31, 2021, and the results of its operations, cash flows, and shareholders’ equity for the three- and nine-month periodsthree months ended June 30, 2021 and 2020, and cash flows for the nine-month periods ended June 30,December 31, 2021 and 2020. These Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and footnotes thereto included in the Company’s fiscal 20202021 Annual Report on Form
10-K,
filed with the SEC on November 23, 2020.2021.
It should be noted that the terms revenue and/or revenues are utilized throughout these notes to the Condensed Consolidated Financial Statements to indicate net revenue and/or net revenues.
The consolidated results of operations for interim periods are not necessarily indicative of the results to be expected for the year. The preparation of these Condensed Consolidated Financial Statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the Condensed Consolidated Financial Statements and the reported amounts of revenues and expenses during the period. Included within these estimates are those related to the ongoing impacts of the
COVID-19
pandemic, which has had both positive and negative effects on our business; positive effects on our Life Science segment and negative effects on our Diagnostics segment. Actual results could differ from those estimates.the estimates made by management.
 
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3.
Significant Accounting Policies
A summary of the Company’s significant accounting policies is included in Note 1 to the audited consolidated financial statements of the Company’s fiscal 20202021 Annual Report on Form
10-K,
filed with the SEC on November 23, 20202021, and should be referred to for a description of the Company’s significant accounting policies.
 
(a)
Recent Accounting Pronouncements –
Pronouncements Adopted
On October 1, 2020,2021, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”)
2016-13,2019-12,
Measurement of Credit LossesIncome Taxes (Topic 740): Simplifying the Accounting for Income Taxes
(“ASU
on Financial Instruments2019-12”),
, which changedclarified and simplified accounting for income taxes by eliminating certain exceptions for intraperiod tax allocation principles, the impairment model used to measure credit lossesmethodology for most financial assets. Use of the new forward-looking expected credit loss model for our accounts receivable valuation, rather than the previously utilized incurred credit loss model, resultedcalculating income tax rates in an immaterialinterim period, and recognition of deferred taxes for outside basis differences in an investment, among other updates. Adoption of ASU
2019-12
did not have a material impact on the Condensed Consolidated Financial Statements.
Pronouncements Issued but Not Yet Adopted as of June 30,December 31, 2021
In March 2020, the FASB issued ASU
2020-04,
Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting
, to provide temporary optional guidance relating to reference rate reform, particularly as it relates to easing the potential burden resulting from the expected discontinuation of the London Interbank Offered Rate (“LIBOR”). The guidance provides practical expedients and exceptions for applying GAAP to contracts, hedging relationships and other transactions affected by reference rate reform if certain criteria are met, which may be applied through December 31, 2022. The Company continues to evaluate the impacts of this guidance but does not expect its application to have a material impact on the Condensed Consolidated Financial Statements.
In December 2019, the FASB
No other new accounting pronouncements recently adopted or issued ASU
2019-12,
Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes
(“ASU
2019-12”).
ASU
2019-12
clarifies and simplifies accounting for income taxes by eliminating certain exceptions for intraperiod tax allocation principles, the methodology for calculating income tax rates in an interim period, and recognition of deferred taxes for outside basis differences in an investment, among other updates. ASU
2019-12
will be effective for the Company’s fiscal year beginning on October 1, 2021. The Company is currently evaluating the impact of ASU
2019-12
but does not expect its applicationhad or are expected to have a material impact on the Condensed Consolidated Financial Statements.
 
(b)
Reclassifications –
Certain reclassifications have been made to the prior year Condensed Consolidated Financial Statements to conform to the current year presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.
 
4.
Revenue Recognition
Overview
Revenue from contracts with customers is recognized in an amount that reflects the consideration we expect to receive in exchange for products when obligations under such contracts are satisfied. Revenue is generally recognized at a
point-in-time
when products are shipped, and control has passed to the customer. Such contracts can include various combinations of products that are generally accounted for as distinct performance obligations. Revenue is reduced in the period of sale for fees paid to distributors, which are inseparable from the distributor’s purchase of our product and for which we receive no goods or services in return. Revenue for the Diagnostics segment is reduced at the date of sale for product price adjustments payable to certain distributors under local contracts.
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Revenue Disaggregation
The following tables present our net revenues disaggregated by major geographic region, major product platform and disease state (Diagnostics segment only):
Revenue
Net Revenues by Reportable Segment & Geographic Region
   
Three Months Ended June 30,
  
Nine Months Ended June 30,
 
   
2021
   
2020
   
Inc (Dec)
  
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                             
Americas
  $24,543   $17,575    40 $73,367   $72,980    1
EMEA
   6,251    3,576    75  18,352    16,853    9
ROW
   395    447    (12)%   1,740    1,498    16
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Total Diagnostics
   31,189    21,598    44  93,459    91,331    2
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Life Science-
                             
Americas
   7,419    22,007    (66)%   39,661    30,638    29
EMEA
   15,723    26,227    (40)%   70,084    41,305    70
ROW
   9,180    14,965    (39)%   38,488    26,240    47
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Total Life Science
   32,322    63,199    (49)%   148,233    98,183    51
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Consolidated
  $63,511   $84,797    (25)%  $241,692   $189,514    28
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Revenue by Product Platform/Type
 
   
Three Months Ended June 30,
  
Nine Months Ended June 30,
 
   
2021
   
2020
   
Inc (Dec)
  
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                             
Molecular assays
  $4,383   $3,182    38 $13,368   $17,259    (23)% 
Non-molecular
assays
   26,806    18,416    46  80,091    74,072    8
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $31,189   $21,598    44 $93,459   $91,331    2
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Life Science-
                             
Molecular reagents
  $20,385   $38,791    (47)%  $104,016   $55,703    87
Immunological reagents
   11,937    24,408    (51)%   44,217    42,480    4
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Total Life Science
  $32,322   $63,199    (49)%  $148,233   $98,183    51
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Revenue by Disease State (Diagnostics segment only)
   
Three Months Ended June 30,
  
Nine Months Ended June 30,
 
   
2021
   
2020
   
Inc (Dec)
  
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
                             
Gastrointestinal assays
  $17,844   $9,584    86 $48,962   $39,644    24
Respiratory illness assays
   3,742    5,052    (26)%   12,233    23,664    (48)% 
Blood chemistry assays
   4,254    3,364    26  13,006    12,508    4
Other
   5,349    3,598    49  19,258    15,515    24
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $31,189   $21,598    44 $93,459   $91,331    2
   
 
 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
   
Three Months Ended December 31,
 
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
               
Americas
  $26,613   $23,551    13
EMEA
   6,093    6,020    1
ROW
   498    750    (34)%
   
 
 
   
 
 
   
 
 
 
Total Diagnostics
   33,204    30,321    10
Life Science-
               
Americas
   8,137    18,755    (57)% 
EMEA
   28,648    32,311    (11)% 
ROW
   18,352    11,530    59
   
 
 
   
 
 
   
 
 
 
Total Life Science
   55,137    62,596    (12)% 
   
 
 
   
 
 
   
 
 
 
Consolidated
  $88,341   $92,917    (5)% 
   
 
 
   
 
 
   
 
 
 
 
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Table of Contents
Net Revenues by Product Platform/Type
   
Three Months Ended December 31,
 
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
               
Molecular assays
  $4,752   $4,590    4
Non-molecular
assays
   28,452    25,731    11
   
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $33,204   $30,321    10
   
 
 
   
 
 
   
 
 
 
Life Science-
               
Molecular reagents
  $31,488   $46,029    (32)% 
Immunological reagents
   23,649    16,567    43
   
 
 
   
 
 
   
 
 
 
Total Life Science  $55,137   $62,596    (12)% 
   
 
 
   
 
 
   
 
 
 
Net Revenues by Disease State (Diagnostics segment only)
   
Three Months Ended December 31,
 
   
2021
   
2020
   
Inc (Dec)
 
Diagnostics-
               
Gastrointestinal assays
  $21,619   $15,452    40
Respiratory illness assays
   6,380    4,806    33
Blood chemistry assays
   78    4,394    (98)% 
Other
   5,127    5,669    (10)% 
   
 
 
   
 
 
   
 
 
 
Total Diagnostics
  $33,204   $30,321    10
   
 
 
   
 
 
   
 
 
 
Royalty Income
Royalty income received from a third party related to sales of
H. pylori
products, totaled approximately $1,380$1,040 and $160 $860
in the three months ended June 30, 2021 and 2020, respectively, and $5,085 and $2,365 in the nine months ended June 30,December 31, 2021 and 2020, respectively. Such revenue is included as part of
Non-molecular
assays and Other within the RevenueNet Revenues by Product Platform/Type and RevenueNet Revenues by Disease State tables, respectively, above.
Reagent Rental Arrangements
Revenue allocated to the lease elements of Reagent Rental arrangements totaled approximately $950 $
995
and $1,150 $
880
in the
three
months ended June 30, December 
31
,
2021
and
2020 respectively, and $2,730 and $3,400 in the nine months ended June 30, 2021 and 2020,
, respectively. Such revenue is included as part of net revenues in our Condensed Consolidated Statements of Operations.
 
5.
Fair Value Measurements
Certain assets and liabilities are recorded at fair value in accordance with Accounting Standards Codification (“ASC”) 820,
Fair Value Measurements and Disclosures
(“ASC 820”). ASC 820 defines fair value as the price that would be received to sell an asset or would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC 820 establishes a three-level hierarchy, which prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy level assigned to each asset and liability is based on the assessment of the transparency and reliability of the inputs used in the valuation of such items at the measurement date based on the lowest level of input that is significant to the fair value measurement. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements).
Assets and liabilities measured and reported at fair value are classified and disclosed in one of the following categories based on inputs:
Level 1
Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities
Level 2
Quoted prices in markets that are not active and financial instruments for which all significant inputs are observable, either directly or indirectly
Level 3
Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable
To limit exposure to volatility in the LIBOR interest rate, the Company has entered into interest rate swap agreements, which effectively convert the variable interest rate on $50,000 of the outstanding revolving credit facility discussed in Note 1112 to a fixed rate. The fair values of the interest rate swap agreements were determined by reference to a third-party valuation, andwhich is considered a Level 2 input within the fair value hierarchy of valuation techniques.techniques, and totaled a
$347
 asset and a 
$203
liability, as of December 31, 2021 and September 30, 2021, respectively.
As describedindicated in Note 6, we acquired Exalenz Bioscience Ltd. (“Exalenz”) in fiscal 2020.the BreathTek business on July 31, 2021. The fair values of theinventories acquired accounts receivable, inventories, property, plant and equipment, and other current assets and the fair values of the assumed accounts payable and accrued expenses were valued using Level 2 inputs, which included data points that were observable, such as appraisals or established values of comparable assets and historical sales information (market approach). IntangibleIdentifiable intangible assets, specifically the acquired customer relationships, were valued using Level 3 inputs, which are unobservable by nature, and included internal estimates of future cash flows and attrition rates (income approach). Significant increases (decreases) in any of those unobservable inputs, as of the date of the acquisition, in isolation would result in a significantly lower (higher) fair value measurement. Management engaged a third-party valuation firm to assist in the determination of the purchase accounting fair values, and specifically those considered Level 3 measurements. Management ultimately oversees the third-party valuation firm to ensure that the transaction-specific assumptions are appropriate for the Company.
 
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6.
Business Combinations
In connection with
On July 31
, 2021 (“the BreathTek acquisition ofdate”), we acquired the BreathTek business, of GenePOC, Inc. (“GenePOC”) in fiscal 2019 and subsequent amendments to modify certain terms of the agreement related to contingent consideration achievement levels and milestone dates, the Company is required to make contingent consideration payments of up to $64,000 (originally $70,000 at the acquisition date), comprised of up to $14,000 for achievement of product development milestones (originally $20,000 at the acquisition date) and up to $50,000 for achievement of certain financial targets. The fair valuea urea breath test for the contingentdetection of
H. pylori
, from Otsuka America Pharmaceutical, Inc. Cash consideration recognized upon thetotaled $19,585, subject to a $1,000
 holdback, which is recorded in acquisition as part of the purchase price allocation was $27,202. The fair value of the product development milestone payments is estimated by discounting the probability-weighted contingent payments to present value and is presentedconsideration on the Condensed Consolidated Balance Sheets, based onto secure the Company’s anticipated dateselling party’s performance of payment at each reporting period. Assumptions used incertain post-closing obligations that is payable 15 months following the calculations include probability of success, duration of the
earn-out
and discount rate, and such calculations were updated for the effectBreathTek acquisition date. As part of the previously noted amendmentsacquisition, we acquired BreathTek inventories and assumed the customer relationships to supply the BreathTek product in North America. The acquired inventories and customer relationships were valued on July 31, 2021 on a preliminary basis, at 
$9,855 and $9,730, respectively, with the useful life of the customer relationships estimated at five years
. There have been no material purchase price adjustments to the contingent consideration achievement levelspreliminary inventories and milestone dates. The fair value of the financial performance target payments was determined using a Monte Carlo simulation-based model. Assumptions used in these calculations include expected revenues, probability of certain developments, expected expenses and discount rate. The ultimate settlement of contingent consideration could deviate significantly from the current Level 3 measurement estimates, based on the actual results of these financial measures.
The following table provides information by level for financial assets and liabilities that are measured at fair value on a recurring basis:
       
Fair Value Measurements Using

Inputs Considered as
 
   
Carrying

Value
   
Level 1
   
Level 2
   
Level 3
 
Interest rate swaps -
                    
As of June 30, 2021
  $(245)  $0     $(245)  $0   
As of September 30, 2020
  $(713)  $0     $(713)  $0   
Contingent consideration -
                    
As of June 30, 2021
  $(15,404)  $0     $0     $(15,404
As of September 30, 2020
  $(20,909)  $0     $0     $(20,909
6.
Business Combinations
On April 30, 2020 (“the acquisition date”), we acquired 100% of the outstanding common shares and voting interest of Exalenz, a Modi’in, Israel based provider of the BreathID
®
Breath Test Systems (“BreathID”), a breath test platform for the detection of
Helicobacter pylori.
Cash consideration totaled 168.6 million New Israeli Shekels (“NIS”), which equated to $48,237 at the date of closing. Including debt assumed and repaid shortly after closing, the total consideration transferred was $56,305. To finance the acquisition, the Company utilized cash and cash equivalents on hand and proceeds drawn from our revolving credit facility (see Note 11). In anticipation of the transaction, we executed forward currency contracts to acquire the NIS required for the acquisition. As a result, the net cash outlay for the transaction prior to the repayment of debt was $47,392.
As a result of total consideration exceeding the fair value of the net assets acquired, goodwill in the amount of $24,798 was recorded in connection with this acquisition, none of which will be deductible for U.S. tax purposes. The goodwill results largely from our ability to market and sell the BreathID platformcustomer relationships values through our established customer base and distribution channels.
Page 11

December 31, 2021. The Company’s consolidated results for the three and nine monthsthree-month period ended June 30,December 31, 2021 and 2020 include the following
$5,611 of net revenues from Exalenz:
   
Three Months
   
Nine Months
 
   
Ended June 30,
   
Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Net revenues
  $4,836   $1,308   $10,718   $1,308 
Net loss
  $(497   (932   (2,236   (932
sales of BreathTek products, which contributed approximately $1,600 of net earnings. These results, which are reported as part of the Diagnostics segment, include amortization expense related to specific identifiable assetsthe customer relationships recorded in the purchase price allocation including a
non-compete
agreement, trade name, technology and customer relationships, totaling $720 and $2,240 for the three and nine months ended June 30, 2021, respectively; $448 for both the three and nine months ended June 30, 2020.
The recognized amounts of identifiable assets acquired and liabilities assumed in the acquisition of Exalenz are as follows:
   
April 30,
2020
 
Fair value of assets acquired -
     
Cash
  $5,006 
Accounts receivable
   637 
Inventories
   4,026 
Other current assets
   2,676 
Property, plant and equipment
   528 
Goodwill
   24,798 
Other intangible assets (estimated useful life):
     
Non-compete
agreement (5 years)
   110 
Trade name (10 years)
   3,860 
Technology (15 years)
   6,120 
Customer relationships (10 years)
   20,640 
Right-of-use
assets
   1,311 
Deferred tax assets, net
   6,780 
   
 
 
 
    76,492 
   
 
 
 
  
Fair value of liabilities assumed -
     
Accounts payable and accrued expenses (including current portion of lease and government grant obligations)
   8,008 
Long-term lease obligations
   1,096 
Long-term government grant obligations
   10,792 
Other
non-current
liabilities
   291 
   
 
 
 
    20,187 
   
 
 
 
Total consideration paid (including $8,068 to pay off long-term debt)
  $56,305 
   
 
 
 
During the three months ended June 30, 2021, the purchase price allocation was finalized.
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Pro Forma Information
$486.
The following table provides the unaudited condensed consolidated pro forma results for the periods presented as if Exalenzthe BreathTek business had been acquired as of the beginning of fiscal 2020 (October 1, 2019). Pro forma results do not include the effect of any synergies achieved or anticipated to be achieved from the acquisition, and accordingly, are not necessarily indicative of the results that would have occurred if the acquisition had occurred on the date indicated or that may result in the future.2021:
 
   
Three Months
Ended June 30,
   
Nine Months
Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Net revenues
  $63,511   $85,083   $241,692   $196,978 
Net earnings
   11,669    27,403    64,750    38,433 
These unaudited pro forma amounts have been calculated by including the results of Exalenz and adjusting the results to give effect to the following, as if the acquisition had been consummated on October 1, 2019, together with the consequential tax effects thereon:
   
Three Months
Ended June 30,
   
Nine Months
Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Adjustments to net revenues
                    
Exalenz
pre-acquisition
net revenues
  $0     $286   $0     $7,464 
   
 
 
   
 
 
   
 
 
   
 
 
 
Adjustments to net earnings
                    
Exalenz
pre-acquisition
net loss
  $0     $(4,919  $0     $(6,423
Pro forma adjustments:
                    
Meridian acquisition-related costs
   0      1,641    0      3,428 
Exalenz transaction-related costs
   0      4,104    0      4,550 
Gain on Exalenz purchase price currency contracts
   0      (845   0      (845
Remove net impact of
non-continuing
personnel, locations or activities
   0      (446   0      (301
Incremental depreciation and amortization
   0      (240   0      (2,064
Interest, net
   0      444    0      (328
Tax effects of pro forma adjustments and recognizing benefit on resulting Exalenz losses
   0      157    0      723 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total adjustments to net earnings
  $0     $(104  $0     $(1,260
   
 
 
   
 
 
   
 
 
   
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Three Months Ended December 31,
  2021   2020 
Net revenues
  $88,341   $97,824 
Net earnings
   15,340    28,014 
 
7.
Cash and Cash Equivalents
Cash and cash equivalents include the following:
   
June 30,
2021
   
September 30,
2020
 
 
Institutional money market funds
  $1,017   $1,017 
Cash on hand, unrestricted
   68,995    52,497 
   
 
 
   
 
 
 
Total
  $70,012   $53,514 
   
 
 
   
 
 
 
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8.
Inventories, Net
Inventories, net are comprised of the following:
   
June 30,
2021
   
September 30,
2020
 
 
Raw materials
  $18,654   $11,966 
Work-in-process
   23,570    19,477 
Finished goods - instruments
   1,975    1,594 
Finished goods - kits and reagents
   27,614    28,227 
   
 
 
   
 
 
 
Total
  $71,813   $61,264 
   
 
 
   
 
 
 
9.
Leasing Arrangements
The Company is party to several operating leases, the majority of which are related to office, warehouse and manufacturing space. The related operating lease assets and obligations are reflected within
right-of-use
assets, net, current operating lease obligations and long-term operating lease obligations on the Condensed Consolidated Balance Sheets. Lease expense for these leases is recognized on a straight-line basis over the lease term, with variable lease payments recognized in the period those payments are incurred.
The lease costs for these operating leases reflected in our Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2021 and 2020, as well as the
right-of-use
assets, net obtained during these periods in exchange for operating lease liabilities, are as follows:
   
Three Months
Ended June 30,
   
Nine Months
Ended June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Lease costs within cost of sales
  $213   $165   $569   $424 
Lease costs within operating expenses
   390    330    1,151    889 
Right-of-use
assets, net obtained in exchange for operating lease liabilities
   381    1,394    1,073    1,616 
In addition, the Company periodically enters into other short-term operating leases, generally with an initial term of twelve months or less. These leases are not recorded on the Condensed Consolidated Balance Sheets and the related lease expense is immaterial for the three and nine months ended June 30, 2021 and 2020.
The Company often has options to renew lease terms, with the exercise of lease renewal options generally at the Company’s sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at our discretion. We evaluate renewal and termination options at the lease commencement date to determine if we are reasonably certain to exercise the option on the basis of economic factors. The discount rate implicit within our leases is generally not determinable and, therefore, the Company uses its incremental borrowing rate as the basis for its discount rate. The weighted average remaining lease term for our operating leases and the weighted average discount rate used to measure our operating leases as of June 30, 2021 and September 30, 2020 were as follows:
   
June 30,
2021
  
September 30,
2020
 
 
Weighted average remaining lease term
   3.7 years   4.2 years 
Average discount rate
   3.2  3.7%
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Maturities of lease liabilities by fiscal year for the Company’s operating leases were as follows as of June 30, 2021:
2021 (represents remainder of fiscal year)
  $613 
2022
   2,202 
2023
   1,590 
2024
   1,213 
2025
   913 
Thereafter
   385 
   
 
 
 
Total lease payments
   6,916 
Less amount of lease payments representing interest
   (380
   
 
 
 
Total present value of lease payments
  $6,536 
   
 
 
 
Supplemental cash flow information related to the Company’s operating leases are as follows:
Nine Months Ended June 30,
  
2021
   
2020
 
 
Cash paid for amounts included in the measurement of lease liabilities:
          
Operating cash flows from operating leases
  $1,611   $1,213 
   
 
 
   
 
 
 
10.
Goodwill and Other Intangible Assets, NetLead Testing Matters
DuringOn September 1, 2021, the nine months ended JuneCompany’s wholly owned subsidiary Magellan announced the expansion of a Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated in May 2021. Customers generally run controls when they receive a new lot of product and reported to us that the control results were outside of specified ranges. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the plastic containers used for the treatment reagent, additional studies have indicated that the root cause relates to the third-party-sourced cardboard trays that hold the containers used for the treatment reagent. The Company continues to work closely with the FDA in its execution of the recall activities, which include notifications to customers and distributors, and providing instructions for the return of impacted test kits. The evaluation of the recall, the related notification process and correction of the identified supplier issue is ongoing. Of the approximate
$5,100
 estimated and accrued as of September 30, 2021 goodwill increased $1,129, reflecting: (i) an additional $332 acquisition measurement period adjustment related to Exalenz (see Note 6); (ii) an $80 increase fromcover the currency translation adjustment on goodwill in the Diagnostics segment; and (iii) a $717 increase from the currency translation adjustment on goodwill in the Life Science segment.
The Company has historically performed its annual goodwill impairment assessment asestimated costs of the last day of the third fiscal quarter of each year (June 30). During the third quarter of fiscal 2021, the Company decided to change the date of its annual impairment assessment from June 30 to July 1. The change was made to more closely align the annual goodwill impairment assessment date with the Company’s annual planningrecall, approximately 
$4,300
remains accrued and budgeting process, as well as its long-term planning and forecasting process. The Company has determined this change in accounting principle is preferable and will not affect the consolidated financial statements. Pursuant to the authoritative accounting literature, in fiscal 2021 the Company will perform a goodwill impairment assessment as of the last day of its fiscal 2021 third quarter (June 30), as well as July 1, to ensure that the change in goodwill impairment assessment date did not delay or avoid an impairment charge. This change is not applied retrospectively, as it is impracticable to do so because retrospective application would require application of significant estimates and assumptions with the use of hindsight. Accordingly, the change will be applied prospectively.
At June 30, 2021, impairment review of the Company’s goodwill consisted of a qualitative assessment for each of our Diagnostics and Life Science reporting units. A qualitative assessment is first performed to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying value using qualitative indicators. In the event that the reporting unit does not pass the qualitative assessment, the reporting unit’s carrying value is compared to its fair value, with fair value of the reporting unit estimated using market value and discounted cash flow approaches. Both our Diagnostics and Life Science reporting units satisfied the qualitative assessment at June 30, 2021, and no impairment was recognized. The Company will perform its July 1, 2021 goodwill impairment assessment during the fourth quarter of fiscal 2021.
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A summary of other intangible assets, net subject to amortization is as follows:
   
June 30, 2021
   
September 30, 2020
 
   
Gross
Carrying
Value
   
Accumulated
Amortization
   
Gross
Carrying
Value
   
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
  $62,451   $21,714   $62,363   $18,750 
Trade names, licenses and patents
   18,530    9,225    18,425    7,801 
Customer lists, customer relationships and supply agreements
   45,305    18,687    45,071    16,210 
Non-compete
agreements
   110    26    110    11 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $126,396   $49,652   $125,969   $42,772 
   
 
 
   
 
 
   
 
 
   
 
 
 
The aggregate amortization expense for these other intangible assets was $2,090 and $2,155 for the three months ended June 30, 2021 and 2020, respectively, and $6,453 and $5,604 for the nine months ended June 30, 2021 and 2020, respectively. The estimated aggregate amortization expense for these other intangible assets for each of the fiscal years through fiscal 2026 is as follows: remainder of fiscal 2021 – $2,000, fiscal 2022 – $7,995, fiscal 2023 – $7,980, fiscal 2024 – $7,975, fiscal 2025 – $7,965, and fiscal 2026 – $7,295.
11.
Bank Credit Arrangements
The Company maintains a revolving credit facility with a commercial bank in an aggregate principal amount not to exceed $160,000, which expires in May 2024. Outstanding principal amounts bear interest at a fluctuating rate tied to, at the Company’s option, either the federal funds rate or LIBOR, resulting in an effective interest rate of 2.52% and 2.63% on the revolving credit facility during the three months ended June 30, 2021 and 2020, respectively, and 2.55% and 3.45% during the nine months ended June 30, 2021 and 2020, respectively. In light of the interest being determined on a variable rate basis, the fair value of the borrowings under the revolving credit facility at both June 30, 2021 and September 30, 2020, approximates the current carrying value reflected in the Condensed Consolidated Balance Sheets.
The revolving credit facility is collateralized bySheet as of December 31, 2021. Anticipated recall-related costs, which primarily include product replacement and/or refund costs, mailing/shipping costs, attorneys’ fees, and other miscellaneous costs are estimated based upon the business assets of the Company’s U.S. subsidiaries and requires compliance with financial covenants that limit the amount of debt obligations and require a minimum level of coverage of fixed charges, as definedmost recent information available. Information utilized in the revolving credit facility agreement. As of June 30, 2021,accrual estimation process includes observable inputs such as customer
on-hand
inventory data, product sales data, average sales price, and product inventory turns, among other things. Available information is subject to change as the Company was in compliance with all covenants.
12.
Contingent Obligations and
Non-Current
Liabilities
In connection with the acquisition of Exalenz (see Note 6), the Company assumed several Israeli government grant obligations. The repayment of the grants, along with interest incurred at varying stated fixed rates based on LIBOR at the time each grant was received (ranging from 0.58% to 6.60%), is not dictated by an established repayment schedule. Rather, the grantsrecall period extends, and related interest are required tosuch changes will be repaid using 3% of the revenues generated from the sales of BreathID products, with the timing of repayment contingent upon the level and timing of such revenues. In addition, the grants have no collateral or financial covenant provisions generally associated with traditional borrowing instruments. These obligation amounts total $11,247 and $11,124 as of June 30, 2021 and September 30, 2020, respectively, and are reflectedrecorded in the Condensed Consolidated Balance Sheets as follows:​​​​​​​​​​​​​​
   
June 30,
2021
   
September 30,
2020
 
Current liabilities
  $735   $600 
Non-current
liabilities
  $10,512   $10,524 
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Additionally, the Company has provided certain post-employment benefits to its former Chief Executive Officer, and these obligations total $1,730 and $1,840 at June 30, 2021 and September 30, 2020, respectively. In addition, the Company is required by the governments of certain foreign countriesperiod known. There have been no material changes in which we operate to maintain a level of accruals for potential future severance indemnity. These accruals total $756 and $814 at June 30, 2021 and September 30, 2020, respectively
.
13.
National Institutes of Health Contracts
In December 2020, the Company entered into a
sub-award
grant contract with the University of Massachusetts Medical School as part of the National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative to support the Company’s research and development of its diagnostic test for the
SARS-CoV-2
antigen. The Company has received $1,000 under the grant contract for reimbursement of eligible research and development expenditures. These amounts are included within other income (expense) in the Condensed Consolidated Statement of Operations for the nine months ended June 30, 2021.
Effective February 1, 2021, the Company entered into a second grant contract under the RADx initiative, the purpose of which is to support the Company’s manufacturing production
scale-up
and expansion to meet the demand for
COVID-19
testing. The contract is a twelve-month term service contract, with payment of up to $5,500 being made based on the Company achieving key milestonesestimates related to increasing its capacity to produce
COVID-19
tests. No amounts related to this contract are reflected within the Condensed Consolidated Financial Statements.
14.
Reportable Segment and Major Customers Information
During the three and nine months ended June 30, 2021, products related to
COVID-19
accounted for approximately 45% and 60%, respectively, of Life Science segment revenues, and 23% and 37%, respectively, of consolidated revenues. In addition, on a consolidated basis, two Life Science segment customers (Customers D and E below) represented 17% and 11%, respectively, of consolidated revenuesLeadCare recall reserve during the three months ended June 30, 2020 (1% and 2%, respectively, during the three months ended June 30, 2021), with no individual Diagnostics or Life Science segment customer accounting for 10% or more of consolidated revenues during the nine months ended June 30, 2021 and 2020.December 31, 2021.
Individual Diagnostics or Life Science segment customers, including their affiliates, comprising 10% or more of reportable segment revenues during any of the three- and nine-month periods ended June 30, 2021 and 2020 were as follows:
   
Three Months
Ended June 30,
  
Nine Months
Ended June 30,
 
   
2021
  
2020
  
2021
  
2020
 
Diagnostics
                 
Customer A
   10  13  11  11
Customer B
   11  8  10  13
Customer C
   14  5  12  5
     
Life Science
                 
Customer D
   3  23  4  17
Customer E
   4  14  12  11
In addition, during the three and nine months ended June 30, 2021, the Life Science segment’s ten largest customers, including their affiliates, accounted for approximately 46% and 43%, respectively, of Life Science segment revenues, and 24% and 27%, respectively, of consolidated revenues.
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One Life Science segment customer (Customer E above) accounted for 15% of consolidated accounts receivable as of September 30, 2020 (2% as of June 30, 2021).
As previously disclosed, o
Reportable segment information for the interim periods is as follows:
   
Diagnostics
  
Life Science
   
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended June 30, 2021
 
Net revenues -
                      
Third-party
  $31,189  $32,322   $—    $—    $63,511 
Inter-segment
   100   54    —     (154  —   
Operating income
   2,510   16,129    (2,998  39   15,680 
Goodwill (June 30, 2021)
   95,267   20,048    —     —     115,315 
Other intangible assets, net (June 30, 2021)
   76,743   1    —     —     76,744 
Total assets (June 30, 2021)
   329,003   117,564    —     3   446,570 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
Three Months Ended June 30, 2020
                      
Net revenues -
                      
Third-party
  $21,598  $63,199   $—    $—    $84,797 
Inter-segment
   86   56    —     (142  —   
Operating income
   (1,783  39,305    (2,849  (8  34,665 
Goodwill (September 30, 2020)
   94,855   19,331    —     —     114,186 
Other intangible assets, net (September 30, 2020)
   83,179   18    —     —     83,197 
Total assets (September 30, 2020)
   306,812   98,483    —     (34  405,261 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
Nine Months Ended June 30, 2021
 
Net revenues -
                      
Third-party
  $93,459  $148,233   $—    $—    $241,692 
Inter-segment
   285   163    —     (448  —   
Operating income
   3,749   92,015    (11,286  67   84,545 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
Nine Months Ended June 30, 2020
 
Net revenues -
                      
Third-party
  $91,331  $98,183   $—    $—    $189,514 
Inter-segment
   264   176    —     (440  —   
Operating income
   8,087   51,564    (7,832  31   51,850 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
(1) 
Includes selected legal costs of $438 and $2,695 in the three and nine months ended June 30, 2021, respectively, and $134 and $1,189 in the three and nine months ended June 30, 2020, respectively.
(2) 
Eliminations consist of inter-segment transactions.
Page 18

A reconciliation of reportable segment operating income to consolidated earnings before income taxes for the interim periods is as follows:
   
Three Months Ended
June 30,
   
Nine Months Ended
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Operating income:
                    
Diagnostics segment
  $2,510   $(1,783  $3,749   $8,087 
Life Science segment
   16,129    39,305    92,015    51,564 
Eliminations
   39    (8   67    31 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total segment operating income
   18,678    37,514    95,831    59,682 
Corporate operating expenses
   (2,998   (2,849   (11,286   (7,832
Interest income
   0      3    15    137 
Interest expense
   (444   (703   (1,450   (2,002
RADx initiative grant income
   0      —      1,000    —   
Other, net
   59    908    (1,515   1,561 
   
 
 
   
 
 
   
 
 
   
 
 
 
Consolidated earnings before income taxes
  $15,295   $34,873   $82,595   $51,546 
   
 
 
   
 
 
   
 
 
   
 
 
 
Transactions between reportable segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.
15.
Income Taxes
The effective rate for income taxes was 24% and 22% for the three and nine months ended June 30, 2021, respectively, and 21% and 23% for the three and nine months ended June 30, 2020, respectively. The variation in effective tax rates during the three and nine months ended June 30, 2021 and 2020 related primarily to higher allocations of taxable income in the U.S. in the fiscal 2021 reporting periods compared to certain lower-rate foreign jurisdictions, particularly the United Kingdom (“U.K.”). Additionally, the nine-month period ended June 30, 2021 was favorably impacted by the effect of current year restricted share unit lapses and stock option exercises occurring on dates when the share price of Company stock was significantly higher than the share price on the date such equity awards were granted, compared to the opposite effect during the prior year period.
16.
Litigation and Regulatory Matters
Onn April 17, 2018
, the
Company’s wholly owned subsidiary Magellan received a subpoena from the U.S. Department of Justice (“DOJ”) regarding its LeadCare
®
product line. The subpoena outlinesoutlined documents to be produced, and the Company is cooperating with the DOJ in this matter. The Company maintains rigorous policies and procedures to promote compliance with applicable regulatory agencies and requirements, and is working with the DOJ to promptly respond to the subpoena, including responding to additional information requests that have followed receipt of the subpoena in April 2018. The Company has executed tolling agreements to extend the statute of limitations. In March and April 2021, DOJ issued two subpoenas calling for witnesses to testify before a federal grand jury related to this matter. The March 2021 subpoena was issued to a former employee of Magellan, and the April 2021 subpoena was issued to a current employee of Magellan. In September and October 2021, DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company’s understanding that multiple witnesses have testified before the federal grand jury and the DOJ’s activity before the federal grand jury is ongoing. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $438
$281 and $134 $1,227
of expense for attorneys’ fees related to this matter is included within the Condensed Consolidated Statements of Operations for the three months ended June 30, 2021 and 2020, respectively, and approximately $2,695 and $1,145 for the nine months ended June 30,December 31, 2021 and 2020, respectively.
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8.
Cash and Cash Equivalents
Cash and cash equivalents include the following:
   
December 31,
2021
   
September 30,
2021
 
 
Institutional money market funds
  $1,020   $1,020 
Cash on hand, unrestricted
   71,709    48,751 
   
 
 
   
 
 
 
Total
  $72,729   $49,771 
   
 
 
   
 
 
 
Cash equivalents, institutional money market funds, are classified within Level 1 of the fair value hierarchy. Financial instruments classified as Level 1 are based on quoted market prices in active markets. The Company does not adjust the quoted market price for such financial instruments.
9.
Inventories, Net
Inventories, net, are comprised of the following:
   
December 31,
2021
   
September 30,
2021
 
 
Raw materials
  $15,104   $14,843 
Work-in-process
   21,479    25,072 
Finished goods - instruments
   2,699    2,260 
Finished goods - kits and reagents
   34,916    34,667 
   
 
 
   
 
 
 
Total
  $74,198   $76,842 
   
 
 
   
 
 
 
10.
Goodwill and Other Intangible Assets, Net
Goodwill is not amortized but is subject to an annual impairment test. Goodwill has been assigned to reporting units within the reportable segments. The Company assesses the carrying value of goodwill annually, or more often if events or changes in circumstances indicate there may be impairment. Impairment testing is performed at a reporting unit level. During the three months ended December 31, 2021, goodwill increased
$45, reflecting: (i) a $4 increase from the currency translation adjustment on goodwill in the Diagnostics segment; and (ii) a $41 increase from the currency translation adjustment on goodwill in the Life Science segment.
During the three months ended December 31, 2021, the Company did not observe any triggering events or substantive changes in circumstances requiring the need for an interim impairment assessment.
A summary of other intangible assets, net, subject to amortization is as follows:
   
December 31, 2021
   
September 30, 2021
 
   
Gross
Carrying
Value
   
Accumulated
Amortization
   
Gross
Carrying
Value
   
Accumulated
Amortization
 
Manufacturing technologies, core products and cell lines
  $62,421   $23,592   $62,416   $22,633 
Trade names, licenses and patents
   18,495    9,806    18,489    9,492 
Customer lists, customer relationships and

supply agreements
   54,954    20,887    54,941    19,649 
Non-compete
agreements
   110    37    110    31 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $135,980   $54,322   $135,956   $51,805 
   
 
 
   
 
 
   
 
 
   
 
 
 
Page 11

The aggregate amortization expense for these other intangible assets was $2,483 and $2,221 for the three months ended December 31, 2021 and 2020
, respectively.
The estimated aggregate amortization expense for these other intangible assets for each of the fiscal years through fiscal 2027 is as follows: remainder of fiscal 2022 – $7,455, fiscal 2023 – $9,925, fiscal 2024 – $9,920, fiscal 2025 – $9,915, fiscal 2026 – $8,920, and fiscal 2027 – $6,645.

11.
Leasing Arrangements
The Company is party to several operating leases, the majority of which are related to office, warehouse and manufacturing space. The related operating lease assets and obligations are reflected within
right-of-use
assets, net, current operating lease obligations, and long-term operating lease obligations on the Condensed Consolidated Balance Sheets. Lease expense for these leases is recognized on a straight-line basis over the lease term, with variable lease payments recognized in the period those payments are incurred.
The lease costs for these operating leases reflected in our Condensed Consolidated Statements of Operations, as well as the
right-of-use
assets, net, obtained during these periods in exchange for operating lease liabilities, are as follows:
Three Months Ended December 31,
  
2021
   
2020
 
Lease costs within cost of sales
  $225   $158 
Lease costs within operating expenses
   388    374 
Right-of-use
assets, net
,
obtained in exchange for operating lease liabilities
   218    80 
In addition, the Company periodically enters into other short-term operating leases, generally with an initial term of twelve months or less. These leases are not recorded on the Condensed Consolidated Balance Sheets and the related lease expense is immaterial for the three months ended December 31, 2021 and 2020.
The Company often has options to renew lease terms, with the exercise of lease renewal options generally at the Company’s sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at our discretion. We evaluate renewal and termination options at the lease commencement date to determine if we are reasonably certain to exercise the option on the basis of economic factors. The discount rate implicit within our leases is generally not determinable and, therefore, the Company uses its incremental borrowing rate as the basis for its discount rate.

The weighted average remaining lease term for our operating leases and the weighted average discount rate used to measure our operating leases were as follows:
   
December 31,
2021
  
September 30,
2021
 
 
Weighted average remaining lease term
   3.3 years   3.6 years 
Average discount rate
   3.2  3.2%
Maturities of lease liabilities by fiscal year for the Company’s operating leases were as follows as of December 31, 2021:
2022 (represents remainder of fiscal year)
  $1,687 
2023
   1,690 
2024
   1,218 
2025
   908 
2026
   316 
Thereafter
   62 
   
 
 
 
Total lease payments
   5,881 
Less amount of lease payments representing interest
   (295
   
 
 
 
Total present value of lease payments
  $5,586 
   
 
 
 
 
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Magellan submitted 510(k) applications in December 2018, seeking to reinstate venous blood sample-types for its LeadCare II, LeadCare Plus and LeadCare Ultra testing systems. In the second fiscal quarter of 2019 the U.S. Food and Drug Administration (“FDA”) informed Magellan that each of these 510(k) applications had been put on Additional Information hold. On July 15, 2019, we provided responses
Supplemental cash flow information related to the FDA’s requests for Additional Information. These 510(k) applications have since expiredCompany’s operating leases is as follows:
Three Months Ended December 31,
  
2021
   
2020
 
Cash paid for amounts included in the measurement of lease liabilities:
          
Operating cash flows from operating leases
  $627   $494 
   
 
 
   
 
 
 
12.
Bank Credit Arrangements
The Company maintains a revolving credit facility with a commercial bank, which on October 25, 2021, was amended primarily to: (i) increase the borrowing capacity from $150,000 to $200,000; (ii) extend the term from May 24, 2024 to October 25, 2026; and are no longer(iii) modify the financial covenants to more closely align with the Company’s size and strategic plans. Other provisions of the credit facility remain unchanged. Outstanding principal amounts bear interest at a fluctuating rate tied to, at the Company’s option, either the federal funds rate or LIBOR, resulting in an effective interest rate
of 2.22% and 2.54% on the revolving credit facility during the three months ended December 31, 2021 and 2020, respectively. In light of the interest being determined on a variable rate basis, the fair value of the borrowings under FDA review. Further, while Magellan’s LeadCare testing systems remain cleared for marketingthe revolving credit facility at both December 31, 2021 and September 30, 2021, approximates the current carrying value reflected in the Condensed Consolidated Balance Sheets of $50,000 and $60,000, respectively, which is consistent with a level 2 fair value measurement.
The revolving credit facility is collateralized by the FDA and permitted for use with capillary blood samples, the FDA advised that it has commissioned a third-party studybusiness assets of the Company’s LeadCare testing systems using both venousU.S. subsidiaries and capillary blood samples. According torequires compliance with financial covenants that limit the FDA,amount of debt obligations and require a minimum level of coverage of fixed charges, as defined in the resultsrevolving credit facility agreement. As of December 31, 2021, the Company was in compliance with all covenants.
13.
Contingent Obligations and
Non-Current
Liabilities
In connection with the acquisition of Exalenz Bioscience Ltd. (“Exalenz”) in fiscal 2020, the Company assumed several Israeli government grant obligations. The repayment of the field study willgrants, along with interest incurred at varying stated fixed rates based on LIBOR at the time each grant was received, is not dictated by an established repayment schedule. Rather, the grants and related interest are required to be usedrepaid
using 3% of the net revenues generated from the sales of BreathID products, with the timing of repayment contingent upon the level and timing of such revenues. In addition, the grants have no collateral or financial covenant provisions generally associated with traditional borrowing instruments.
T
hese obligation amounts total $5,833 and $5,814 as of December 31, 2021 and September 30, 2021, respectively, bearing interest at rates ranging from 0.58% to 2.02%.
The grant obligations are reflected in conjunction with other informationthe Condensed Consolidated Balance Sheets as follows:
   
December 31,
2021
   
September 30,
2021
 
Current liabilities
  $765   $638 
Non-current
liabilities
  $5,068   $5,176 
Additionally, the Company has provided certain post-employment benefits to determine whether further actionits former Chief Executive Officer, and these obligations total $1,639 and $1,676 at December 31, 2021 and September 30, 2021, respectively. In addition, the Company is required by the FDA orgovernments of certain foreign countries in which we operate to maintain a level of accruals for potential future severance indemnity. These accruals total $707 and $754 at December 31, 2021 and September 30, 202
1
, respectively.
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14.
National Institutes of Health Contracts
In December 2020, the Centers for Disease Control and Prevention (“CDC”) is necessary to protect the public health. The Company intends to fully cooperateentered into a
sub-award
grant contract with the FDA or CDC on anyUniversity of Massachusetts Medical School as part of the National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative to support the Company’s research and development of its diagnostic test for the
follow-up
SARS-CoV-2
antigen. During fiscal 2021, the Company received $1,000 under the grant contract for reimbursement of eligible research and development expenditures, $800 of which was received during the three months ended December 31, 2020 and is included within other income (expense) in the Condensed Consolidated Statement of Operations for that period.
Effective February 1, 2021, the Company entered into a second grant contract under the RADx initiative, the purpose of which is to support the Company’s manufacturing production
scale-up
and expansion to meet the demand for
COVID-19
testing. The contract is a twelve-month service contract, with payment of up to $5,500 being made based on the third-party study.Company achieving key milestones related to increasing its capacity to produce
COVID-19
tests.
During October 2019,
As of December 31, 2021: (i)
$1,500 has been received related to this contract and is reflected as a reduction in the FDA performed a
follow-up
inspectioncost of Magellan’s manufacturing facility. The FDA issued five Form FDA 483 observations. On March 18, 2020, we participatedequipment within construction in a regulatory meeting withprogress on the FDA atCondensed Consolidated
Balance Sheet; and (ii) the FDA’s request to further discussCompany was in the Form FDA 483 observations and our remediation efforts. Since the inspection, we have submitted a numberprocess of written responsesfinalizing an amendment to the FDA regardinggrant, which among other things, would increase the five Form FDA 483 observations issuedgrant by $
2,500
to a total of $
8,000
and extend the term by 12 months (see Note 17 for discussion of subsequent amendment to the grant).
15.
Reportable Segment and Major Customers Information
The Company’s reportable segments maintain separate financial information for which results of operations are evaluated on a regular basis by the Company’s chief operating decision maker in deciding how to allocate resources and in assessing performance.
The Company records the October 2019 inspection,direct costs of business operations to the reportable segments, including allocations for certain corporate-wide costs such as treasury management, human resources and have worked diligentlytechnology, among others. Corporate provides certain executive management and administrative services to execute a remediation plan. During October 2020,each reportable segment. These services primarily include executive oversight by
non-segment-specific
executives, including the FDA issued Establishment Inspection Reports which closed outBoard of Directors, along with certain other corporate-wide support functions such as insurance, legal and business development. The Company generally does not allocate these types of corporate expenses to the inspections from June 2017 and October 2019 under 21 C.F.R.20.64(d)(3).reportable segments.
During June 2021, the FDA performed an inspection of Magellan’s manufacturing facility. The inspection followed a voluntary recall, initiated in May 2021, involving certain manufactured lots of its LeadCare II, LeadCare PlusReportable segment and LeadCare Ultra products. As a result of this inspection, the FDA issued one Form 483 observation. The FDA has identified this recall, which remains ongoing, as a Class I recall, and the Company is working closely with the FDA in its execution of the recall activities. Magellan is also responding to ongoingcorporate information requests from the FDA regarding issues related to the recall. Based upon information known at this time, the recall’s impact on the Company’s consolidated financial statements is not believed to be material and no related costs are included within the Condensed Consolidated Statements of Operations for the three and nine months ended June 30, 2021. On August 3, 2021, FDA sent Magellan a close-out letter for the Warning Letter that FDA issued to Magellan on October 23, 2017. FDA’s close-out letter notified Magellan that FDA has completed an evaluation of Magellan’s corrective actions in response to FDA’s Warning Letter, and based on FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. FDA’s close-out letter also stated that future FDA inspections of Magellan and regulatory activities will further assess the adequacy and sustainability of Magellan’s corrections.interim periods is as follows:
   
Diagnostics
  
Life Science
   
Corporate
(1)
  
Eliminations
(2)
  
Total
 
Three Months Ended December 31, 2021
 
Net revenues -
                      
Third-party
  $33,204  $55,137   $—    $—    $88,341 
Inter-segment
   34   55    —     (89  —   
Operating (loss) income
   (2,612  26,517    (3,637  15   20,283 
Goodwill (December 31, 2021)
   94,908   19,805    —     —     114,713 
Other intangible assets, net (December 31, 2021)
   81,656   2    —     —     81,658 
Total assets (December 31, 2021)
   352,318   106,339    —     (17  458,640 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
Three Months Ended December 31, 2020
                      
Net revenues -
                      
Third-party
  $30,321  $62,596   $—    $—    $92,917 
Inter-segment
   69   18    —     (87  —   
Operating (loss) income
   (1,182  39,797    (3,963  12   34,664 
Goodwill (September 30, 2021)
   94,904   19,764    —     —     114,668 
Other intangible assets, net (September 30, 2021)
   84,149   2    —     —     84,151 
Total assets (September 30, 2021)
   339,208   110,536    —     (22  449,722 
   
 
 
  
 
 
   
 
 
  
 
 
  
 
 
 
 
17.
(1) 
Subsequent Event
Includes selected legal costs of $281 and $1,227 in the three months ended December 31, 2021 and 2020, respectively.
On July 22, 2021, the Company signed a definitive agreement to acquire from Otsuka America Pharmaceutical, Inc. (“OAPI”) its BreathTek
®
business in the U.S. and Mexico for $20,000 in cash. BreathTek is an FDA approved urea breath test for the detection of
H. pylori
. Assets to be acquired include test kit inventory, customer relationships and rights to the BreathTek trade name. In addition, the Company and OAPI have entered into a transition services agreement, which is designed to allow the Company to integrate the BreathTek business in a manner that provides appropriate customer support. This transaction closed on July 31, 2021. The purchase price was funded with cash and cash equivalents on hand and this acquisition will be included in our Diagnostics segment.
(2) 
Eliminations consist of inter-segment transactions.
 
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A reconciliation of reportable segment operating (loss) income to consolidated earnings before income taxes for the three months ended December 31, 2021 and 2020, is as follows:
Three Months Ended December 31,
  
2021
   
2020
 
Operating (loss) income:
          
Diagnostics segment
  $(2,612  $(1,182
Life Science segment
   26,517    39,797 
Eliminations
   15    12 
   
 
 
   
 
 
 
Total operating income
   23,920    38,627 
Corporate expenses
   (3,637   (3,963
Interest income
   1    9 
Interest expense
   (372   (534
RADx initiative grant income
   0      800 
Other, net
   (161   (691
   
 
 
   
 
 
 
Consolidated earnings before income taxes
  $19,751   $34,248 
   
 
 
   
 
 
 
Transactions between reportable segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.
Net revenues generated by the Company’s three major Diagnostics segment product families – gastrointestinal, respiratory illnesses and blood chemistry – accounted for 32% and 27% of consolidated net revenues during the three months ended December 31, 2021 and 2020, respectively.
Three individual Diagnostics and two Life Science segment customers, including their affiliates,
comprising 10% or more of reportable segment net revenues were as follows: 
Three Months Ended December 31,
  
2021
  
2020
 
Diagnostics
         
Customer A
   10%  12%
Customer B
   11%  10%
Customer C
   11%  11%
         
Life Science
         
Customer D
   14%  19%
Customer E
   23%  2%
In addition, the two Life Science segment customers, including their affiliates, identified above accounted for greater than 10% of consolidated net revenues as follows:
Three Months Ended December 31,
  
2021
  
2020
 
Life Science
         
Customer D
   9%  13%
Customer E
   14%  2%
No
individual Diagnostics segment customer accounted for greater than 10% of consolidated net revenues during the three months ended December 31, 2021 or 2020.
During the three months ended December 31, 2021 and 2020, the Life Science segment’s ten largest customers, including their affiliates, accounted for approximately
 67% and 55%, respectively, of Life Science segment net revenues, and 42% and 37%, respectively, of consolidated net revenues.

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No Diagnostics or Life Science segment customer accounted for greater than 10% of consolidated accounts receivable as of December 31, 2021, while one Diagnostics segment customer (Customer B above) and one Life Science segment customer (Customer D above) accounted for approximately 12% and 10%, respectively, of consolidated accounts receivable as of September 30, 2021.
16.
Income Taxes
The effective rate for income taxes was approximately
 22%
for each of the three months ended December 31, 2021 and 2020.
17.
Subsequent Event
On January 25, 2022, the Company entered into an amended grant contract under the RADx initiative. The purpose of this grant is to support the Company’s manufacturing production
scale-up
and expansion to meet the demand for
COVID-19
testing, as well as the Company’s Revogene respiratory assay. The amended contract is a twelve-month service contract through January 2023, with payment of up to an additional $2,500 being made based on the Company achieving key milestones related to increasing its capacity to produce
COVID-19
tests and the Revogene respiratory assay, bringing the total possible payment under the grant to $8,000.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Refer to “Forward-Looking Statements” following the Table of Contents in front of this Form
10-Q.
In the discussion that follows, all dollar amounts are in thousands (both tables and text), except per share data.
The purpose of Management’s Discussion and Analysis is to provide an understanding of the financial condition, changes in financial condition and results of operations of Meridian Bioscience, Inc. (“Meridian”, the “Company”, “We”). This discussion should be read in conjunction with the Condensed Consolidated Financial Statements and notes. It should be noted that the terms revenue and/or revenues are utilized throughout the Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) to indicate net revenue and/or net revenues. In addition, throughout the MD&A, we refer to certain product tradenames and trademarks, which are protected under applicable intellectual property laws and are our property. Solely for convenience, these tradenames and trademarks are referred to without the
®
or
symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent of the law, our rights to these tradenames and trademarks.trademar
ks.
Reportable Segments
Our reportable segments are Diagnostics and Life Science. The Diagnostics segment consists of manufacturing operations for infectious disease products in Cincinnati, Ohio; Quebec City, Canada; and Modi’in, Israel; and manufacturing operations for blood chemistry products in Billerica, Massachusetts (near Boston).Massachusetts. These diagnostic test products are sold and distributed in the countries comprising North and Latin America (the “Americas”); Europe, Middle East and Africa (“EMEA”); and other countries outside of the Americas and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; and Luckenwalde, Germany, and the sale and distribution of bulk antigens, antibodies, immunoassay blocking reagents, various Polymerase Chain Reaction (“PCR”) master mixes, and bioresearch reagents domestically and abroad, including a sales and business development facility, with outsourced distribution capabilities, in Beijing, China to further pursue growing revenue opportunities in Asia.
Page 16

Recent Developments
During
Impact of
COVID-19
Pandemic
Starting in the latter half of fiscal 2020 and continuing to the first halfdate of fiscal 2021,this filing, the
COVID-19
pandemic has had both positive and negative effects on our businesses. The third quarter of fiscal 2021 represents the first quarter since the early stages of the
COVID-19
pandemic that our Diagnostics segment has shown positive revenue growth versus the same quarter in fiscal 2020. Conversely for our Life Science segment, the third quarter of fiscal 2021 represents the first quarter since the early stages of the
COVID-19
pandemic that its revenues have shown a decline compared to the same quarter in fiscal 2020.business.
Our Life Science segment’s products have been well positioned to respond to
in-vitro
in vitro device (“IVD”) manufacturers’ needsincreased demand for reagents forused in the manufacture of molecular, rapid antigen and serology tests. Consequently, our Life Science segment grew itshas consistently delivered significantly higher levels of net revenues over 100%and operating income than those achieved prior to the COVID-19 pandemic, with the to date peak in such levels occurring during the third quarter of fiscal 2020 and delivered record operating income and margin, demonstrating what this segment could achieve at a much larger scale. This higher-than-historical level of growth continued into the first halfquarter of fiscal 2021, for the Life Science segment before declining during the three months ended June 30, 2021. In recent months, we have experienced a decline in the demand for our Life Science segment’s reagent products used in
COVID-19
tests and as a result, our Life Science segment’s revenues during the three months ended June 30, 2021 decreased 49% from the prior year period, while the segment’s revenues during the fiscal 2021
year-to-date
nine-month period increased 51% over the comparable fiscal 2020 period.respectively.
Our Diagnostics segment, on the other hand, reportedhas generally been negatively impacted by health systems’ increased year-over-year revenuesfocus on
COVID-19
testing over traditional infectious disease testing. The impacts of 44% and 2% for the three- and nine-month periods ended June 30, 2021, respectively. Following decreasing year-over-year revenues
COVID-19
pandemic are most dramatically evident in the last two quarters34% year-over-year decline in revenues from respiratory illness assays in fiscal 2021, following flat year-over-year revenue levels experienced in fiscal 2020. Reflecting what we believe to be the start of a return to
pre-pandemic
activity levels, during the first quarter of fiscal 2022, revenues from respiratory illness assays were 33% higher than the first quarter of fiscal 2021 and 18% lower than the
pre-pandemic
first quarter of fiscal 2020, and first two quarters ofa marked improvement over the aforementioned 34% decline in fiscal 2021, these results indicate signs of a return to more normal
pre-pandemic
levels of revenue in all product areas except for respiratory illness products. Revenue from sales of respiratory illness assays continues to compare unfavorably to fiscal 2020, down 26% and 48% for the three and nine months ended June 30, 2021, respectively.2021.
Despite these recent
COVID-19
pandemic related trends, due to the many uncertainties surrounding the
COVID-19
pandemic, we can provide no assurances with respect to our views of the longevity or severity of the positive or negative impacts to our consolidated financial condition of the ongoing
COVID-19
pandemic.
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Employee Safety
While our employee base in the U.S. has returned to working
on-site
at our facilities, we have implemented a hybrid work-from-home program for certain personnel, and we continue to utilize a work-from-home process as needed on a
site-by-site
basis outside the U.S. for those employees whose
on-site
presence has been deemed to be
non-essential.
We have also implementedcontinue to utilize enhanced cleaning and sanitizing procedures and providedprovide additional personal hygiene supplies at all our sites. We have implemented policies for employees to adhere to CDCCenters for Disease Control and Prevention (“CDC”) guidelines on social distancing, and similar guidelines by authorities outside the U.S. To date, we have been able to manufacture and distribute products globally, and all our sites have continued to operate with little, if any, impact on shipments to customers to date. As the
COVID-19
pandemic continues, along with continuing governmental restrictions which vary by locale and jurisdiction, there is an increased risk of employee absenteeism, which could materially impact our operations at one or more sites. To date, the steps we have taken, including our work-from-home processes, have not materially impacted the Company’s financial reporting systems, internal controls over financial reporting or disclosure controls.
Supply Chains
Supply chains supporting our products have generally remained intact, providing access to sufficient inventory of the key materials needed for manufacturing. To date,While we have experienced extended lead times for certain select raw materials, delays and allocations for raw materials have to date been limited and have not had a material impact on our results of operations. From time to time, we identify alternative suppliers to address the risk of a current supplier’s inability to deliver materials in volumes sufficient to meet our manufacturing needs; or we may choose to purchase certain materials in bulk volumes where we have supply chain scarcity concerns. It remains possible that we may experience some sort of interruption to our supply chains, and such an interruption could materially affect our ability to timely manufacture and distribute our products and unfavorably impact our results of operations.
We are also starting to experience input cost inflation, including materials and labor. Pricing actions and supply chain productivity initiatives have mitigated and are expected to continue to mitigate some of these inflationary pressures, but we may not be successful in fully offsetting these incremental costs, which could have an impact on the Company’s consolidated results of operations and cash flows during 2022 and beyond.
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Table of Contents
Product Development and Clinical Trials
Our clinical trialsDiagnostics segment’s new product development programs are progressingcontinuing to progress at a slower pace than normal, asdue in part to the prevalence of certain infectious diseases (e.g., bacterial gastrointestinal) hashaving been much lower than normal during the
COVID-19
pandemic. In addition, the relative lack of a respiratory illness season in 2020-2021 has significantly impacted the availability of influenza samples, thereby affecting the pace of development of our molecular respiratory panel for the Revogene system. These matters continue to impact our timing for filing applications for product clearances with the FDA,U.S. Food and Drug Administration (“FDA”), as well as related timing of FDA clearances of such filings. Additionally, the ongoing
COVID-19
pandemic has slowed and could continue to slow down our efforts to expand our product portfolio through acquisitions andand/or distribution opportunities, impacting the speed with which we are able to bring additional products to market.
Product Demand
Our Life Science segment manufactures, markets and sells a number of molecular and immunological reagents to IVD customers, including those who are making both molecular and immunoassay
COVID-19
tests. Since late in the second quarter of fiscal 2020, we have generally experienced unprecedented demand for certain of our molecular reagents (e.g., ribonucleic acid (“RNA”) master mixes and nucleotides). However, as expected, to date, including a resurgence in such demand during the second half of our fiscal 2021 we have experienced a decline infourth quarter and throughout the demand for our Life Science segment’s reagent products used in
COVID-19
tests, as health care systems transition to more asymptomatic testing versus the predominant symptomatic testing we saw during the peakfirst quarter of the
COVID-19
pandemic.fiscal 2022. While we expect a continuation of this trend, throughout the remainder of our fiscal year ending September 30, 2021, this expectation couldwill certainly be impacted by the recent resurgence in
COVID-19
infection rates, particularly those associated with the
COVID-19
strain commonly known as the “Delta variant”, with infection rates and the responses to such levels of infection varying by country based on their individual
COVID-19
case statistics, infection rates and vaccine programs. We believe that our reagent products for
COVID-19
have applications in many alternative,
non-hospital-based
channels (e.g., airports, schools, etc.). Our products are used in over 100 regulatory agency approved
COVID-19
related assays around the world.
COVID-19
related reagent revenues totaled approximately $14,500 and $88,500 in the three and nine months ended June 30, 2021, respectively, compared to approximately $48,000 and $53,000 in the three and nine months ended June 30, 2020, respectively, and approximately $71,500 during full year fiscal 2020.
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Table of Contents
Our Diagnostics segment manufactures, markets and sells a number of molecular, immunoassay, blood chemistry and urea breath tests
for various infectious diseases and blood-lead levels. Sales volumes for a number of these assays have been adversely affected by the
COVID-19
pandemic over the past year and half,two years, as such assays are often used in
non-critical
care settings. However, as previously noted, during the three months ended June 30, 2021,settings; however, we have begun to see signsseen indications of a return to more normal
pre-pandemic
levels for most of our Diagnostics segment product lines, with respiratory illness assays being the exception.levels. The
COVID-19
pandemic also has affecteddepressed instrument orders and placements for our BreathID, Curian and Revogene platforms. Recently, we are seeing higher levels of order activity for our BreathID platform. However, orderOrder activity for our Revogene platform continues to bewas affected by our pending
SARS-CoV-2
assaythe delay in obtaining emergency use authorization (“EUA”) application, which we voluntarily withdrew from the FDA on February 23, 2021 and resubmitted on June 25, 2021. We believefor our
SARS-CoV-2
assay, as customers have takentook a “wait and see” approach withthroughout our entire EUA application resubmission.process. We received the EUA on November 9, 2021 but have not yet begun to ship product, as our
SARS-CoV-2
assay is currently being enhanced to detect the recently prevalent Omicron variant of the
COVID-19
infection. We anticipate completing the validation of these changes during the second quarter of fiscal 2022, with shipment of product to commence thereafter upon clearance by the FDA. Despite the situation encountered with our EUA application for the
SARS-CoV-2
assay and the delay in shipment due to the Omicron variant related enhancements, we are inhave proceeded with the process of increasing our capacity to produce these tests, as well as other tests on the Revogene system,platform, at our sitesfacilities in Quebec and Cincinnati. Specifically, we are: (i) addinghave added a second production line at our Quebec manufacturing facility;facility and (ii)are installing two additional production lines in a leased facility near our corporate headquarters in Cincinnati. It is expected thatWith approximately $11,700 expended on these expansion efforts willthrough December 31, 2021, we expect them to be completed during calendar 20212022 at a total cost of approximately $18,000,$21,300, which is expected to be partially offset by the $5,500 RADxmonies received under the National Institutes of Health Rapid Acceleration of Diagnostics (“RADx”) initiative grant entered into on February 1, 2021, and as amended on January 25, 2022, $1,500 of which had been received as of December 31, 2021 (see Note 1314,
“National Institutes of the Condensed Consolidated Financial Statements).Health Contracts”
and Note 17,
Critical Accounting Estimates“Subsequent Event”
Aside from the change in the Company’s annual goodwill impairment assessment discussed in Note 10 of the Condensed Consolidated Financial Statements for further discussion).
Critical Accounting Estimates
For the three and nine months ended June 30,December 31, 2021, there were no significant changes to our critical accounting estimates, as outlined in our Annual Report on Form
10-K
as of and for the year ended September 30, 2020.2021, filed with the SEC on November 23, 2021.
Page 18

Impact of Brexit
Lead Testing Matters
The U.K. leftOn September 1, 2021, the European Union (“EU”) on January 31, 2020. While all EU rules and laws continued to applyCompany’s wholly owned subsidiary Magellan announced the expansion of the Class I voluntary recall of its LeadCare test kits for the detection of lead in blood, which it had initiated in May 2021 after identifying an ongoing issue with the testing controls included in certain manufactured lots of its LeadCare test kits. As a result of the identified issue, impacted test kit lots could potentially underestimate blood lead levels when processing patient blood samples. Although it was initially believed that the root cause of the issue related to the U.K. throughplastic containers used for the transition period,treatment reagent, additional studies have indicated that the root cause relates to the third-party-sourced cardboard trays that hold the containers used for the treatment reagent. The Company continues to work closely with the FDA in its execution of the recall activities, which include Magellan notifying customers and distributors affected by the recall and providing instructions for the return of impacted test kits. The evaluation of the recall, the related notification process and correction of the identified supplier issue is ongoing. Of the approximate $5,100 estimated and accrued as of September 30, 2021 to cover the estimated costs of the recall, approximately $4,300 remains accrued and is reflected in the Condensed Consolidated Balance Sheet as of December 31, 2021. Anticipated recall-related costs primarily include product replacement and/or refund costs, mailing/shipping costs, attorneys’ fees and other miscellaneous costs.
As previously disclosed, on April 17, 2018, the Company’s wholly owned subsidiary Magellan received a subpoena from the U.S. Department of Justice (“DOJ”) regarding its LeadCare product line. The subpoena outlined documents to be produced, and the Company is cooperating with the DOJ in this matter. The Company maintains rigorous policies and procedures to promote compliance with applicable regulatory agencies and requirements and is working with the DOJ to promptly respond to the subpoena, including responding to additional information requests that have followed receipt of the subpoena in April 2018. The Company has executed tolling agreements to extend the statute of limitations. In March and April 2021, DOJ issued two subpoenas calling for witnesses to testify before a federal grand jury related to this matter. The March 2021 subpoena was issued to a former employee of Magellan, and the April 2021 subpoena was issued to a current employee of Magellan. In September and October 2021, DOJ issued additional subpoenas to individuals seeking testimony and documents in connection with its ongoing investigation. It is the Company’s understanding that multiple witnesses have testified before the federal grand jury and the DOJ’s activity before the federal grand jury is ongoing. The Company cannot predict when the investigation will be resolved, the outcome of the investigation, or its potential impact on the Company. Approximately $281 and $1,227 of expense for attorneys’ fees related to this matter is included within the Condensed Consolidated Statements of Operations for the three months ended December 31, 2020, the U.K. and the EU reached a free trade agreement on December 24, 2020, which was ratified on April 28, 2021 and went into effect2020, respectively.
Having issued a Warning Letter to Magellan on May 1, 2021.October 23, 2017 related to the Billerica location’s manufacturing of LeadCare testing systems for venous blood samples (the “Warning Letter”), on August 3, 2021, the FDA sent Magellan a
close-out
letter for the Warning Letter. The agreement includesFDA’s
close-out
letter notified Magellan that the FDA has completed an evaluation of Magellan’s corrective actions in response to the FDA’s Warning Letter, and based on the FDA’s evaluation, Magellan has addressed the issues identified in the Warning Letter. The FDA’s
close-out
letter also stated that future FDA inspections of Magellan and regulatory activities will further assess the adequacy and customs cooperation mechanisms, as well as provisions supporting open and fair competition. Undersustainability of Magellan’s corrections. For a more detailed discussion of this matter, see the trade agreement,“Lead Testing Matters” section beginning on page 29 of the U.K. is free to set its own trade policy and can negotiate with other countries that do not currently have free trade dealsCompany’s fiscal 2021 Annual Report on Form
10-K,
filed with the EU. Although the full impact of the trade agreement is uncertain, it is possible that the recent changes to the trading relationship between the U.K. and the EU due to the trade agreement could result in increased cost of goods imported into and exported from the U.K., which may decrease the profitability of our operations. Additional currency volatility could drive a weaker British pound, which could increase the cost of goods imported into the U.K. and may decrease the profitability of our operations. A weaker British pound versus the U.S. dollar may also cause local currency results of our operations to be translated into fewer U.S. dollars during a reporting period. Given the lack of comparable precedent, it is unclear what financial, trade, regulatory and legal implications the trade agreement will haveSEC on our business; however, Brexit and its related effects could potentially have an adverse impact on our consolidated financial position and results of operations.
The U.K.’s withdrawal from the EU could also adversely impact the operations of our vendors and of our other partners. Our management team has evaluated a range of possible outcomes, identified areas of concern, and implemented strategies to help mitigate these concerns. It is possible that these strategies may not be adequate to mitigate any adverse impacts of Brexit, and that these impacts could further adversely affect our business and results of operations.
November 23, 2021.
RESULTS OF OPERATIONS
Three Months Ended June 30,December 31, 2021
Net earnings for the three months ended June 30, 2021first quarter of fiscal 2022 decreased 58%43% to $11,669,$15,340, or $0.26$0.35 per diluted share, from net earnings for the thirdfirst quarter of fiscal 20202021 of $27,507,$26,779, or $0.64$0.61 per diluted share. The level of net earnings in the thirdfirst quarter of fiscal 2021 was affected predominantly by2022 resulted primarily from the declinedecrease in net revenues and operating income in our Life Science segment, stemming fromwhen compared to the softening inrecord demand for the reagents utilized in
COVID-19
related reagentstests during the quarter.first quarter of fiscal 2021. As a significant number of our Life Science segment customers use our molecular reagents in multiple tests, including
non-COVID-19
related tests, it has become increasingly difficult to accurately estimate the portion of molecular reagent sales related specifically to
COVID-19.
As a result, we are no longer reporting the portion of Life Science segment net revenues related to
COVID-19.
Such net revenues were identified and reported throughout fiscal 2021 and totaled approximately $43,000 and $111,900 in the first quarter and full year of fiscal 2021, respectively.
Consolidated net revenues for the thirdfirst quarter of fiscal 20212022 totaled $63,511,$88,341, a decrease of 25%5% compared to the thirdfirst quarter of fiscal 2020 (29% decrease on a constant-currency basis).2021.
Page 23

TableNotwithstanding the impact of Contents
Revenuesthe LeadCare recall, net revenues from the Diagnostics segment for the thirdfirst quarter of fiscal 2022 increased 10% compared to the first quarter of fiscal 2021, increased 44% compared to the third quarter of fiscal 2020 (42% increase on a constant-currency basis), comprised of a 38%4% increase in molecular assay products and a 46%an 11% increase in
non-molecular
assay products. The thirdfirst quarter of fiscal 20212022 represents the firstthird consecutive quarter since the early stages of the
COVID-19
pandemic that our Diagnostics segment has shown positive revenue growth versus the same quarter in the prior fiscal 2020.year. Our Diagnostics segment generated $2,500 ina $2,600 operating incomeloss for the thirdfirst quarter of fiscal 2022, compared to a $1,200 operating loss in the first quarter of fiscal 2021, an increase of $4,300 overreflecting the third quarter of fiscal 2020.
With a 47% decrease in revenues from molecular reagent productsgross profit margins and a 51% decreaseincrease in revenues from immunological reagent products, revenues for our Life Science segment decreased 49% during the third quarter of fiscal 2021 compared to the third quarter of fiscal 2020. On a constant-currency basis, revenues for the Life Science segment decreased 52%. Life Science segment revenues reflect a significant decreaseoperating expenses described in the demand from diagnostic test manufacturers for the reagents utilized in
COVID-19
related tests, as the demand for such tests has declined. However, revenue from sales of our core Life Science segment products (other than
COVID-19
contributions) experienced growth of over $2,000, or approximately 15%, compared to the third quarter of 2020. This growth resulted in large part from obtaining business from
COVID-19
customers who are now using our products for other
non-COVID-19
related purposes, as well as a rebound in volumes in core immunological products. Our Life Science segment generated $16,100 of operating income for the third quarter of fiscal 2021, a decline of $23,200 from the third quarter of fiscal 2020.
Nine Months Ended June 30, 2021
Net earnings for the nine-month period ended June 30, 2021 increased 63% to $64,750, or $1.47 per diluted share, from net earnings for the comparable fiscal 2020 period of $39,693, or $0.92 per diluted share. The level of net earnings in the first nine months of fiscal 2021 was affected predominantly by the strong first half increase in revenues and operating income in our Life Science segment, stemming from the demand for
COVID-19
related reagents.
Consolidated revenues increased 28% to $241,692 for the first nine months of fiscal 2021 compared to the same period of the prior year (24% increase on a constant-currency basis).
Diagnostics segment revenues increased 2% (1% on a constant-currency basis), comprised of a 23% decrease in molecular assay products and an 8% increase in
non-molecular
assay products. Our Diagnostics segment generated operating income of $3,700 for the first nine months of fiscal 2021, a decline of $4,300 compared to the first nine months of fiscal 2020.
With an 87% increase in revenues from molecular reagent products and a 4% increase in revenues from immunological reagent products, revenues for our Life Science segment increased 51% during the first nine months of fiscal 2021 compared to the same period of the prior year. On a constant-currency basis, revenues for the Life Science segment increased 44%. Life Science segment revenues during the first nine months of fiscal 2021 reflect a significant increase in sales of key molecular components such as RNA master mixes and deoxyribonucleotide triphosphates (“dNTPs”) to diagnostic test manufacturers for use in
COVID-19
related PCR tests. Also contributing to the increased revenue levels during the fiscal 2021
year-to-date
period were sales of monoclonal antibody pairs used in
COVID-19
antigen tests and, to a lesser degree, recombinant antigens used in
COVID-19
antibody tests. In addition, revenue from sales of our core Life Science segment products (other than
COVID-19
contributions) experienced growth of approximately $14,500, or approximately 33%, during the first nine months of fiscal 2021 compared to the same period of the prior year. This growth resulted in large part from obtaining business from
COVID-19
customers who are now using our products for other
non-COVID-19
related purposes, as well as a rebound in volumes in core immunological products. Our Life Science segment generated $92,000 of operating income for the first nine months of fiscal 2021, an increase of over $40,000 compared to the first nine months of fiscal 2020.
Lead Testing Matters
During the past three fiscal years, various regulatory matters have arisen related to Magellan and the Company’s blood lead test manufacturing facility. See Note 16 of the Condensed Consolidated Financial Statements for discussion of these matters.
While we remain committed to strengthening Magellan’s quality system and ensuring that all aspects of the system are in full compliance, we do not expect that the FDA will reinstate our venous blood claims. We can provide no assurance that the ongoing investigation and regulatory activity of the DOJ and FDA discussed in Note 16 of the Condensed Consolidated Financial Statements, or future exercise of their respective enforcement, regulatory, discretionary or other powers will not result in findings or alleged violations of federal laws that could lead to enforcement actions, proceedings or litigation, and/or the imposition of damages, fines, penalties, restitution, other monetary liabilities, sanctions, injunctions, settlements or changes to our business practices, product offerings or operations that could have a material adverse effect on our business, consolidated financial condition or results of operations; or eliminate altogether our ability to operate our lead testing business on terms substantially similar to those on which we currently operate.
sections below.
 
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Table of Contents
With a 32% decrease in net revenues from molecular reagent products, and a 43% increase in net revenues from immunological reagent products, net revenues for our Life Science segment decreased 12% during the first quarter of fiscal 2022 compared to the first quarter of fiscal 2021, the period in which the Life Science segment experienced near unprecedented demand from diagnostic test manufacturers for use in
COVID-19
related tests. Our Life Science segment generated $26,500 of operating income for the first quarter of fiscal 2022, a decline of $13,300 from the first quarter of fiscal 2021, primarily resulting from the decrease in net revenues and gross profit margins described in the respective sections below.
REVENUE OVERVIEW
Below are analyses of the Company’s net revenues, provided for each of the following:
 
 -
By Reportable Segment & Geographic Region
 
 -
By Product Platform/Type
Revenue Overview- By Reportable Segment & Geographic Region
Revenues for the Diagnostics segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major distributors, seasonality and severity of seasonal diseases and outbreaks (including the
COVID-19
pandemic), and foreign currency exchange rates. Revenues for the Life Science segment, in the normal course of business, may be affected from quarter to quarter by buying patterns of major IVD manufacturing customers, severity of disease outbreaks (including the
COVID-19
pandemic), and foreign currency exchange rates. The severity of the
COVID-19
pandemic contributed approximately $71,500 of new revenue for our Life Science segment during fiscal 2020 including approximately $48,000 and $53,000 in the three and nine months ended June 30, 2020, respectively. This compares to approximately $14,500 and $88,500 of such revenue during the three and nine months ended June 30, 2021, respectively.
See the “Revenue Disaggregation” section of Note 4,
“Revenue Recognition”
of the Condensed Consolidated Financial Statements for detailed revenue disaggregation information.
Following is a discussion of the net revenues generated by these product platforms/types and/or disease states:
Diagnostics Segment Products
The acquisitions of the Revogene molecular diagnostics platform and the BreathID breath test system, the development of the Curian immunoassay platform, and the expansion of the related assay-menu for each of these platforms are important stepsDiagnostics segment’s overall 10% growth in addressing competitive pressures in our gastrointestinal and respiratory illness assay families.
In March 2020, we received clearance from the FDA for the Curian immunoassay diagnostics instrument and its first assay, a test for
H. pylori
antigen in stool. We began clinical trials for the Curian
C. difficile
Common Antigen and Toxins A and B testnet revenues during the secondfirst quarter of fiscal 2022 compared to the first quarter of fiscal 2021, and submitted a 510(k)
pre-market
notification toprimarily results from the FDA for marketing clearance of Curian Campylobacter on March 31, 2021. We believe the advantagescombined effects of the Curian analyzer will help protect our existing rapid test accounts, andfollowing:
Volume growth in the case of the
C. difficile
test, provide meaningful revenue growth opportunities.
Gastrointestinal, Respiratory Illness and Blood Chemistry Assays
As previously noted, the ongoing
COVID-19
pandemic has had a negative impact on revenue levelsgastrointestinal products benefitting from sales of our gastrointestinal,the BreathTek product, acquired on July 31, 2021 (approximately $5,600 of net revenues from BreathTek in the first quarter of fiscal 2022);
Volume growth in sales of respiratory illness and blood chemistry products. Comprisedproducts, comprised of tests for Group A Strep, Mycoplasma pneumonia, Influenza, and Pertussis, among others, reflecting an increase in the respiratory illness category in particular continues to experience significantly lower sales activity relativetesting for these illnesses compared to the prior year, with revenues from sales of such products decreasing 26% and 48% during the third quarter and first nine months of fiscal 2021, respectively. However, during the third quarter of fiscal 2021, we experienced an increase in sales activity for gastrointestinaldespite the ongoing
COVID-19
pandemic; and blood chemistry products for the second consecutive quarter, with revenues from each of these product categories increasing as follows compared to the third quarter of fiscal 2020: (i) gastrointestinal products, which include tests for
C. difficile
,
H. pylori
and certain foodborne pathogens, among others, increased 86% to $17,844; and (ii) blood chemistry products, which test for elevated levels of lead in blood, increased 26% to $4,254. During the first nine months of fiscal 2021, gastrointestinal product revenues increased 24% over the prior year period to $48,962, and blood chemistry product revenues increased 4% to $13,006. The increases in the
H. pylori
component of our gastrointestinal family of products include contributions from the BreathID urea breath platform acquired in the Exalenz acquisition on April 30, 2020.
 
Page 25
Volume declines from sales of blood chemistry products due to the ongoing LeadCare product recall, which commenced in May 2021 ($4,316 decrease in net revenues compared to the first quarter of fiscal 2021).

In order to combat certain of the pricing and volume pressures we face within the gastrointestinal product category, we have executed on a number of measures including: (i) operating under a strategic collaboration with DiaSorin to sell
H. pylori
tests; (ii) executing long-term supply agreements with reference laboratory customers for
H. pylori
tests to secure volume, albeit at lower selling prices; and (iii) upon FDA clearance in March 2020, launching Curian HpSA, our first assay on the Curian platform, which we expect will help protect our existing customer base using lateral flow tests. We also expect the BreathID platform to combat competitive pressures, as we believe that we are now the only company with
FDA-cleared,
non-invasive
assays for both stool antigen and urea breath samples, providing physicians a choice in test format from a single supplier. We are unable to provide assurances that we will be successful with any strategy or that any strategy will prevent an adverse effect on our future results of operations and liquidity, including revenues and gross profit.
Life Science Segment Products
DuringDespite continuing to achieve net revenues levels that are significantly higher than
pre-pandemic
levels, the thirdLife Science segment’s 12% decline in net revenues during the first quarter of fiscal 2022 primarily results from a year-over-year quarterly comparison to the record levels of demand achieved during the first quarter of fiscal 2021. As previously noted, it was during the first quarter of fiscal 2021 revenues fromthat our Life Science segment decreased 49%, with revenues from molecular reagent sales decreasing 47% from the comparable fiscal 2020 quarter and revenues from immunological reagent sales decreasing 51%. Life Science segment revenues increased 51% for the first nine months of fiscal 2021, reflecting an 87% increase from molecular reagent sales and a 4% increase in immunological reagent sales. The quarterly decrease in Life Science segment revenue results primarily from the continued reduction in diagnostic test manufacturers’experienced near unprecedented demand for reagents associated with
COVID-19.
It is this demand from diagnostic test manufacturers throughout the peak of the
COVID-19
pandemic that resulted in the increase in fiscal
year-to-date
revenues. The increase resulted specifically from demand for key molecular components such as RNA master mixes and dNTPs toits products by diagnostic test manufacturers for use in
COVID-19
related PCR tests, as well as sales of monoclonal antibody pairs used in antigen tests and to a lesser degree, recombinant antigens used in
COVID-19
antibody tests.
COVID-19-related
reagent revenues totaled approximately $14,500 and $88,500 during the third quarter and first nine months of fiscal 2021, respectively, compared to approximately $48,000 and $53,000 in the three and nine months ended June 30, 2020, respectively.
During the third quarter of fiscal 2021, revenue from sales of our core Life Science segment products (other than
COVID-19
contributions) grew approximately 15% over the third quarter of fiscal 2020 to approximately $17,500. During the first nine months of fiscal 2021, such revenue grew approximately 33% over the comparable fiscal 2020 period to approximately $59,000. This growth resulted in large part from obtaining business from
COVID-19
customers who are now using our products for
non-COVID-19
related purposes, as well as a rebound in volumes of core immunological product sales.
Significant Customers
Revenue concentrations related to certain customers within our Diagnostics and Life Science segments are set forth in Note 14 15,
“Reportable Segments and Major Concentration Data”
of the Condensed Consolidated Financial Statements.
Gross Profit
   
Three Months Ended June 30,
  
Nine Months Ended June 30,
 
   
2021
  
2020
  
Change
  
2021
  
2020
  
Change
 
Gross profit
  $37,111 $55,983    (34)%  $156,431  $118,180  32
Gross profit margin
   58  66  -8 points   65  62  +3 points 
The movements in gross profit margins during both the third quarter and first nine months of fiscal 2021 are primarily attributable to the overall shifts in sales mix the Company has experienced in connection with the
COVID-19
pandemic. During the nine-month period ended June 30, 2021, which included the peak of the
COVID-19
pandemic, approximately 43% of consolidated revenues related to sales of molecular reagent products, which are some of our higher margin products. This compares to approximately 29% during the first nine months of fiscal 2020.
 
Page 26

As the demand for such molecular reagent products for use in
COVID-19
test manufacturing declined during the fiscal 2021 third quarter, such products comprised a smaller relative percentage of consolidated revenue; approximately 32% in the third quarter of fiscal 2021 compared to approximately 46% in the third quarter of fiscal 2020. Additionally, the current period margins have been unfavorably impacted by production capacity
ramp-up
costs for our Quebec facility, where Revogene instruments and test devices are made.
Operating Expenses – Segment Detail
   
Three Months Ended June 30,
 
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
  
Total Operating
Expenses
 
Fiscal 2020:
         
Diagnostics
  $6,129  $5,009  $6,279  $(4,387 $13,030
Life Science
   539   1,273   3,630   (3  5,439
Corporate
   —      —      2,715   134  2,849
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Total Expenses (2020 Quarter)
  $6,668  $6,282  $12,624  $(4,256 $21,318
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Fiscal 2021:
         
Diagnostics
  $5,463  $4,966  $6,140  $(3,263 $13,306
Life Science
   620   1,243   3,264    —     5,127
Corporate
   —      —      2,560   438  2,998
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Total Expenses (2021 Quarter)
  $6,083  $6,209  $11,964  $(2,825 $21,431
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
   
Nine Months Ended June 30,
 
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
  
Total Operating
Expenses
 
Fiscal 2020:
         
Diagnostics
  $15,037  $15,806  $16,853  $(3,575 $44,121
Life Science
   1,709   3,733   8,740   195  14,377
Corporate
   —      —      6,643   1,189  7,832
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Total Expenses (2020
Year-to-Date)
  $16,746  $19,539  $32,236  $(2,191 $66,330
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Fiscal 2021:
         
Diagnostics
  $16,011  $15,914  $18,441  $(5,205 $45,161
Life Science
   1,788   3,856   9,795    —     15,439
Corporate
   —      —      8,591   2,695  11,286
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Total Expenses (2021
Year-to-Date)
  $17,799  $19,770  $36,827  $(2,510 $71,886
  
 
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Operating Expenses – Comparisons to Prior Year Periods
   
Three Months Ended June 30,
 
   
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2020 Expenses
  $6,668  $6,282  $12,624  $(4,256 $21,318
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
% of Revenues
   8  7  15  (5)%   25
Fiscal 2021 Increases/(Decreases):
      
Diagnostics
   (666  (43  (139  1,124   276
Life Science
   81   (30  (366  3   (312
Corporate
   —     —     (155  304   149
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
2021 Expenses
  $6,083  $6,209  $11,964  $(2,825 $21,431
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
% of Revenues
   10  10  19  (4)%   34
% Increase (Decrease)
   (9)%   (1)%   (5)%   34  1
Page 2720

Total operating expenses for
Gross Profit
   
Three Months Ended December 31,
 
   
2021
  
2020
  
Change
 
Gross Profit
  $49,159  $61,548   (20)% 
Gross Profit Margin
   56  66  -10 points 
Overall gross profit margins during the thirdfirst quarter of fiscal 2022 have been unfavorably impacted by a decline in net revenues contributions from our Life Science segment’s molecular reagent products, which are some of our highest margin products. During the first quarter of fiscal 2022, approximately 36% of consolidated net revenues related to sales of molecular reagent products, compared to approximately 50% during the first quarter of fiscal 2021, showwhen the Life Science segment experienced the to date peak in net revenues from sales of molecular reagent products.
Additionally, overall gross profit margins in the first quarter of fiscal 2022 have been unfavorably impacted in our Diagnostics segment by the previously discussed LeadCare product recall (see “Lead Testing Matters” above) and production capacity
ramp-up
costs at our Cincinnati and Quebec Revogene manufacturing facilities.
Operating Expenses – Segment Detail and Corporate
   
Research &
Development
   
Selling &
Marketing
   
General &
Administrative
   
Other
   
Total Operating
Expenses
 
Fiscal 2021 First Quarter:
                         
Diagnostics
  $5,070   $5,728   $5,748   $1,047   $17,593 
Life Science
   581    1,293    3,454    —      5,328 
Corporate
   —      —      2,736    1,227    3,963 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total 2021 First Quarter Expenses
  $5,651   $7,021   $11,938   $2,274   $26,884 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Fiscal 2022 First Quarter:
 
Diagnostics
  $5,556   $6,009   $7,143   $—     $18,708 
Life Science
   638    1,732    4,161    —      6,531 
Corporate
   —      —      3,356    281    3,637 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total 2022 First Quarter Expenses
  $6,194   $7,741   $14,660   $281   $28,876 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Compared to the prior year period, operating expenses increased $1,992 to $28,876 in the first quarter of fiscal 2022. Major components of this increase were as follows:
Increased Research & Development costs, reflecting increased clinical trial spending and product development costs within our Diagnostics segment;
Increased Selling & Marketing costs in both the Diagnostics and Life Science segments, primarily reflecting the effects of filling certain open positions and the easing of certain travel and meeting restrictions imposed during the prior year in connection with the
COVID-19
pandemic; and
Increased General & Administrative costs, primarily reflecting the combined effects of additional investment in incentive compensation, the timing of certain outside services costs and increased commercial insurance costs for Directors & Officers and Property & Casualty coverages.
Page 21

Offsetting these increases were: (i) a net increase of 1%, This net increase primarily includes two components. The change$1,047 year-over-year decrease in expense within our Diagnostics segment, resulting from the adjustment to the fair value of contingentacquisition consideration was a decline of $3,563 in the 2021 quarter compared to a decline of $6,124 in the 2020 quarter, which results in an increase in net expense of $2,561 between periods. This is increase is largely offset by decreases in other operating expenses, predominantly Diagnostics segment research and development spending and corporate-wide general and administrative expenses.
   
Nine Months Ended June 30,
 
   
Research &
Development
  
Selling &
Marketing
  
General &
Administrative
  
Other
  
Total Operating
Expenses
 
2020 Expenses
  $16,746 $19,539 $32,236 $(2,191 $66,330
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
% of Revenues
   9  10  17  (1)%   35
Fiscal 2021 Increases/(Decreases):
      
Diagnostics
   974  108  1,588  (1,630  1,040
Life Science
   79  123  1,055  (195  1,062
Corporate
   —     —     1,948   1,506   3,454
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
2021 Expenses
  $17,799 $19,770 $36,827  (2,510 $71,886
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
% of Revenues
   7  8  15  (1)%   30
% Increase (Decrease)
   6  1  14  (15)%   8
Total operating expenses for the first nine months of fiscal 2021 show a net increase of 8%, This increase primarily includes three components. The change in the fair value of contingent consideration was a decline of $5,505 in fiscal 2021
year-to-date
period compared to a decline of $7,428 in the comparable fiscal 2020 period, which results in an increase in net expense of $1,923 between periods. Other operating expenses in 2021 include a full nine months of costs related to the Exalenz business acquired in April 2020, including purchase accounting amortization,first quarter; and (ii) lower spending on selected legal costs increased $1,506 related to our
on-goingcosts.
DOJ matter.
Operating Income
Compared to the prior year periods,period, operating income decreased 55%41% to $15,680 for$20,283 in the thirdfirst quarter of fiscal 2021 and increased 63% to $84,545 for the first nine months of fiscal 2021,2022, as a result of the factors discussed above.
Income Taxes
The effective rate for income taxes was 24% andapproximately 22% for both the threefirst quarter of fiscal 2022 and nine months ended June 30, 2021, respectively,fiscal 2021.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of reviewing our prices to consider the impacts of inflation on salaries and 21%fringe benefits for employees and 23% for the threecost of purchased materials and nine months ended June 30, 2020, respectively. The variation in effective tax rates during the threeservices. Inflation and nine months ended June 30, 2021 and 2020 related primarily to higher allocations of taxablechanging prices did not have a material adverse impact on our gross margin, revenues or operating income in the U.S. in thefirst quarter of fiscal 2021 reporting periods compared to certain lower-rate foreign jurisdictions, particularly the U.K. Additionally, the nine-month period ended June 30, 2021 was favorably impacted by the effect of current year restricted share unit lapses and stock option exercises occurring on dates when the share price of Company stock was significantly higher than the share price on the date such equity awards were granted, compared to the opposite effect during the prior year period.2022 or fiscal 2021.
Liquidity and Capital Resources
Liquidity
Our cash flow and financing requirements are determined by analyses of operating and capital spending budgets and debt service. We have historically maintained a credit facility to augment working capital requirements and to respond quickly to acquisition opportunities.
We have an investment policy that guides the holdings of our investment portfolio, which presently consists of bank savings accounts and institutional money market mutual funds. Our objectives in managing the investment portfolio are to: (i) preserve capital; (ii) provide sufficient liquidity to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii) capture a market rate of return commensurate with market conditions and our policy’s investment eligibility criteria. As we look forward, we will continue to manage the holdings of our investment portfolio with preservation of capital being the primary objective.
Page 28

We intend to continue to fund our working capital requirements from current cash flows from operating activities and cash on hand. Ifhand, and such sources are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next twelve months. However, if needed, we also have an additional source of liquidity through the amount remaining available on our $160,000$200,000 bank revolving credit facility, which totaled $110,000$150,000 as of June 30,December 31, 2021. Our liquidity needs may change if overall economic conditions worsen and/or liquidity and credit within the financial markets tightens for an extended period, and such conditions impact the collectability of our customer accounts receivable, impact credit terms with our vendors, or disrupt the supply of raw materials and services.
During the first nine months of fiscal 2021, we generated cash flow from operations totaling $52,386. This represents a 65% increase over the comparable prior year period, reflecting a higher level of net earnings.
Our levels of inventories increased $10,549 to $71,813 between September 30, 2020 and June 30, 2021. This increase was largely attributable to inventory builds in our Life Science segment to protect against future supply interruptions. For our Diagnostics segment, we also have continued to maintain relatively consistent inventory levels in anticipation of a return to
pre-pandemic
diagnostic testing activity. We are continuing to actively manage our inventory levels.
As of June 30,December 31, 2021, our cash and cash equivalents balance was $70,012$72,729 or $16,498$22,958 higher than at the endSeptember 30, 2021. This increase primarily results from generating $35,555 of fiscal 2020. As a result of the cash generatedflow from operations, duringan increase of 42% over the thirdfirst quarter and first nine months of fiscal 2021, and the use of cash to pay down $10,000 on the revolving credit facility.
Considering these factors, our balance of netcash and cash equivalents on hand exceeded our total debt (defined as bank debt, government grant obligations and total contingent obligations related to the acquisition of the GenePOC business, net of cash and cash equivalents
on-hand)
decreasedacquisitions) by approximately $46,700 to approximately $6,600$16,000 at June 30,December 31, 2021. Net cash flows from operating activities and cash on hand are anticipated to be adequate to fund working capital requirements, capital expenditures and debt service during the next twelve months.
Capital Resources
As described in Note 11,12,
“Bank Credit Arrangements”
of the Condensed Consolidated Financial Statements, the Company maintains a $160,000$200,000 revolving credit facility, which is secured by substantially all of our U.S. assets and includes certain restrictive financial covenants. The Company also maintains a shelf registration statement on file with the SEC.
Our
Page 22

During fiscal 2022 our capital expenditures are estimated to range betweentotal approximately $18,000$15,000, comprised of approximately $12,000 and $24,000 during fiscal 2021. Our$3,000 in the Diagnostics and Life Science segments, respectively. Included within the Diagnostics segment capital expenditures could be as high as $21,000, depending upon the level and timingestimate is approximately $10,400 related to completion of the previously noted Revogene
COVID-19
assay productionmanufacturing capacity expansion and
scale-up
efforts, and our Life Science segment capital expenditures could be as high as $3,000, reflecting manufacturing capacity expansion at various locations.automation initiatives for Revogene assay production. Such expenditures may be funded with cash and cash equivalents on hand, operating cash flows, and/or availability under the $160,000$200,000 revolving credit facility discussed above. In addition, a portion of the Diagnostics segment expansion may be funded by the remaining amounts to be received under the previously noted $5,500 RADx grant entered into on February 1, 2021, and as amended on January 25, 2022 (see Note 13 14,
“National Institutes of Health Contracts”
and Note 17,
“Subsequent Event”
of the Condensed Consolidated Financial Statements for further discussion).
License Agreements
The Company has entered into various license agreements that require payment of royalties based on a specified percentage of sales of related products. During the first quarter of fiscal 2022, royalty expense totaled approximately $800, with 35% and 65% of such expense relating to our Diagnostics and Life Science segments, respectively. This compares to a total of approximately $450 of royalty expense in the first quarter of fiscal 2021, with 70% and 30% relating to our Diagnostics and Life Science segments, respectively. The Company expects that payments under these agreements will amount to approximately $3,000 in fiscal 2022, a decrease from the $5,200 in fiscal 2021.
Off-Balance
Sheet Arrangements
We utilize foreign currency exchange forward contracts to limit exposure to volatility in foreign currency gains and losses related to financial assets denominated in other than the holding subsidiary’s functional currency. These contracts are generally settled within a
30-day
time frame and are not formally designated or accounted for as accounting hedges. We also utilize interest rate swap agreements to limit exposure to volatility in the LIBOR interest rate in connection with the revolving credit facility. The interest rate swap agreements are designated and accounted for as accounting hedges (see Note 5,
“Fair Value Measurements”
of the Condensed Consolidated Financial Statements).
We Aside from these instruments, we do not utilize any special-purpose financing vehicles or have any material undisclosed
off-balance
sheet arrangements.
Page 29

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of June 30,December 31, 2021, there were no material changes to the information provided under Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” in the Company’s Form
10-K
for the year ended September 30, 2020,2021, filed with the SEC on November 23, 2020.2021.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and Chief FinancialPrincipal Accounting Officer, we have evaluated the effectiveness of the Company’s disclosure controls and procedures, as defined in Rules
13a-15(e)
and
15d-15(e)
under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of June 30,December 31, 2021. Based on this evaluation, our Chief Executive Officer and Chief FinancialPrincipal Accounting Officer have concluded that the Company’s disclosure controls and procedures were effective as of the period covered by this report.
Control systems, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that control objectives are met. Because of inherent limitations in all control systems, no evaluation of controls can provide assurance that all control issues and instances of fraud, if any, within a company will be detected. Additionally, controls can be circumvented by individuals, by collusion of two or more people or by management override. Over time, controls can become inadequate because of changes in conditions or the degree of compliance may deteriorate. Further, the design of any system of controls is based in part upon assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated goals under all future conditions. Because of the inherent limitations in any cost-effective control system, misstatements due to errors or fraud may occur and not be detected.
Page 23

Changes in Internal Control over Financial Reporting
In the ordinary course of business, we routinely enhance our information systems by either upgrading current systems or implementing new ones. There were no changes in our internal control over financial reporting (as that term is defined in Rules
13a-15(f)
and
15d-15(f)
under the Exchange Act) during the quarter ended June 30,December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Information with respect to legal proceedings can be found in Note 16,7,
Litigation and RegulatoryLead Testing Matters”
of the Condensed Consolidated Financial Statements in Part I, Item 1 of this Quarterly Report on Form
10-Q
and is incorporated herein by reference.
ITEM 1A. RISK FACTORS
In addition to the other information set forth in this report, careful consideration should be given to the factors discussed in Item 1A, “Risk Factors” in our Annual Report on Form
10-K
for the year ended September 30, 2020,2021, filed with the SEC on November 23, 2020,2021, as may be supplemented by our Quarterly Reports on Form
10-Q,
any or all of which could materially affect our business, financial condition or future results. The risks described therein are not the only risks facing us. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial, also may adversely affect our business, financial condition and/or operating results. There have been no material changes with respect to the risk factors disclosed in our Annual Report on Form
10-K
for the year ended September 30, 2020,2021, filed with the SEC on November 23, 2020,2021, as may be supplemented by our Quarterly Reports on Form
Form 10-Q.
Page 30


101.INS  Inline XBRL Instance Document
101.SCH  Inline XBRL Instance Extension Schema
101.CAL  Inline XBRL Instance Extension Calculation Linkbase
101.DEF  Inline XBRL Instance Extension Definition Linkbase
101.LAB  Inline XBRL Instance Extension Label Linkbase
101.PRE  Inline XBRL Instance Extension Presentation Linkbase
104  Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Management Compensatory Contracts
+
Certain portions of these exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The omitted information is not material and would likely cause competitive harm to the Registrant if publicly disclosed. The Registrant hereby agrees to furnish a copy of any omitted schedule or other portion to the SEC upon request.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
   
MERIDIAN BIOSCIENCE, INC.
Date:
August 6, 2021February 4, 2022
  By: 
/s/ Bryan T. BaldasareJulie Smith
   Bryan T. Baldasare
Executive Vice President and Chief Financial OfficerJulie Smith
   
Senior Vice President and Controller
(Principal Financial and Accounting Officer)
 
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